Please visit the following additional U.S. firms at MEDICA in the Department of Commerce's USA CEO Center in hall 16, C04:
- Advanced Medical Technology Association (AdvaMed)
- Argentum Medical LLC
- BFW, Inc.
- Calbiotech
- Cincinnati Sub-Zero
- Clarus Medical, LLC
- Contour Products
- CryoPen, Inc.
- eBioscience Corporation
- Ellman International
- FDA - U.S. Food and Drug Administration
- Laser Peripherals, LLC
- Luminetx Corporation
- LuxteL LLC
- Methodize Inc.
- Missouri Partnership
- NuStep, Inc.
- Step Forward Orthotics
- STI Medical Systems
- Timely Medical Innovations, LLC
- Typenex Medical LLC
- UL International Germany GmbH
Advanced Medical Technology Association (AdvaMed)
Washington DC - www.advamed.org
- AdvaMed's member companies produce the medical devices, diagnostic products and health information systems that are transforming health care through earlier disease detection, less invasive procedures and more effective treatments. Their members produce nearly 90 percent of the health care technology purchased annually in the United States and more than 50 percent purchased annually around the world. AdvaMed members range from the largest to the smallest medical technology innovators and companies.
- At MEDICA 2009, AdvaMed is seeking to expand its international network of members and to strengthen its cooperation with associations and institutions with similar goals. AdvaMed welcomes an opportunity to meet with companies and partners at MEDICA who desire to learn more about our capabilities and services.
Argentum Medical LLC
Chicago, Illinois - www.silverlon.com
- Argentum Medical produces Silver Nylon Antimicro bial bandages for wounds, burns, surgery, and consumer use and is seeking to export to the EU.
BFW, Inc.
Louisville, Kentucky - www.bfwinc.com
- BFW is a small company that manufactures and distributes surgical lighting and video systems. BFW is introducing at Medica its surgical headlight/light source system featuring the first new lamp technology introduced since xenon. These lamps provide 10.000 hours of lamp life as opposed to 650 hours of existing lamps used in the OR today. BFW also offers a portable LED headlight system and headlight mounted video camera system. Target countries for BWF at Medica are e.g. Russia, suppliment South and Latin America and South Africa.
Calbiotech
Sping Valley, California - www.calbiotech.com
- Calbiotech is a worldwide provider of Immunoassay products and services. We offer ELISA, lumELISATM (Ultra-Sensitive Chemilumenescent ELISA) and Radioimmunoassay (RIA) products as well as preclinical testing services. Our product line includes: Endocrine, Steroid, Fertility, Cancer, Thyroid and Cardiac, Infectious Disease, Growth Hormone, Allergy and Drug Abuse markers. We can design and customize Immunoassay products to meet your needs and applications. We currently offer customized Immunoassay products for Mouse/Rat, Sheep, Canine, Porcine and other animal species that are used by major pharmaceutical companies, universities and research centers.
- Calbiotech can provide preclinical and research testing services for testing human and animal samples using the Calbiotech Immunoassay menu. We offer very competitive pricing and a fast turnaround time.
- Calbiotech is an FDA registered and ISO 13485:2003 certified facility. We adopted operating policies based on FDA Quality System (QS), current Good Manufacturing Practice (cGMP), Good Laboratory Practices (GLP) and ISO requirements, EU directive and Canadian medical devices regulations.
- Our main customers are reference laboratories, universities, research centers and pharmaceutical companies. Thanks to MEDICA, we would like to find new contacts in Germany, Australia, and Japan.
Cincinnati Sub-Zero
Cincinnati, Ohio - www.cszinc.com
- Cincinnati Sub-Zero develops and manufactures patient temperature management systems for healthcare professionals, including therapeutic heat therapy and cold therapy units along with warming and cooling blankets.
- Seeking distributors particularly in Germany, Italy and the United Kingdom.
Clarus Medical, LLC
Golden Valley, Minnesota - www.clarus-medical.com
- Clarus Medical is dedicated to the advancement of products for less invasive medicine. Clarus manufactures Nucleotome®, a clinically proven, safe and effective device for percutaneous disc decompression as well as other innovative products used in the fields of spine surgery, neurosurgery, and pain management. Clarus Medical also develops reusable, portable, high-resolution fiber optic and digital video endoscopes for intubations/confirmation of ETtubes and LMAs. We partner with other leading medical companies as an OEM manufacturer as well.
Contour Products
Avon Lake, Ohio - www.contourliving.com
- The Contour CPAP Pillow’s patented design accommodates any
respiratory mask for improved comfort and better CPAP Therapy
compliance. The pillow features two “pressure-free zones” where
the mask rests without coming into contact with the pillow to
minimize:
Mask shifting, leaks and hose kinks
Discomfort caused by the mask pressing against the user’s face
The tendency to over-tighten mask straps to compensate for leaks and shifting. - These pressure free zones improve:
Comfort and compliance
Freedom of movement
General usability of the CPAP Therapy equipment - Advanced, upgraded features of the Contour CPAP Pillow included a precisely molded design made of poured foam for a higher quality, more supportive and resilient product. A new thicker cover of silky quilted padding in the hollowed-out sections of the pillow and along the shoulder area ensures that the mask, hose and body easily glide over the pillow when users change positions during the night.
- The pillow’s orthopedic design supports the head, neck and shoulder area to reinforce comfort. Specifically molded sports for a patient’s ears to rest in when side sleeping provide added relief and the pillow’s inclined upper sides support the user’s forehead to help prevent the head from rotating downward, compromising airway alignment.
- The Contour CPAP Pillow is backed by a full five year warranty and boasts great retail packaging that thoroughly conveys the pillow’s features and benefits in a user-friendly format. A full complement of distributor marketing materials is available to help with the promotion of the product.
- The Contour CPAP Pillow is also available with a form-fitting wipe-down cover which is suitable for use in sleep centers.
- The CPAP Pillow would be suitable for distributors who work with Sleep Centers and Durable Medical Equipment/Home Medical Equipment companies. We would like to find distributors in the United Kingdom, Germany, Spain, Australia, Japan and Italy in particular.
CryoPen, Inc.
Covington LA, California - www.cryopen.com
- The CryoPen® uses no cryogenic gases or liquids. It offers the most advanced state-of-the –art cooling technology in the field of cryosurgery. The CryoPen Cryosurgical System is designed to be the most effective and simplest cryosurgical instrument on the market. It is less costly than other current treatments, and is less painful than traditional methods. The CryoPen also offers accurate pen-point precision and a consistent freeze temperature, which can be monitored using the CryoPen Temperature Indicator. With its simple, non-technique dependent procedure, the CryoPen makes cryosurgery safe, simple, and effective.
eBioscience Corporation
San Diego, California - www.ebioscience.com
- For over 10 years eBioscience has provided innovative, high-quality reagents to researchers worldwide that empower the process of discovery in areas of cellular immunity and oncology. eBioscience offers more than 10,000 multi-parametric cell analysis products that allow its customers to gain insight into the mechanisms that control and define cells. Founded in 1999, eBioscience is headquartered in San Diego, California and conducts business in more than 70 countries around the world. We have recently expanded in Europe and now have eBioscience offices in the UK and Germany. A reputation of FIRST and Fast to market with the release of over 600 new targets and format per year A leader in reagent offerings for multicolor flow cytometry, we are focused on pairing new and unique specificities with the ideal fluorochromes and sizes. A leader in technology with introduction of our eBioscience eFluor™ brand of organic and nanocrystal fluorochromes for use in multicolor flow cytometry and imaging A leading manufacturer of a broad portfolio of reagents for cell analysis including high quality antibodies, recombinant proteins (cytokines and growth factors) and fuctional grade antibodies for use in biological assays that require low endotoxin and azide-free conditions. eBioscience would like to make people aware that we are now direct in the UK and Germany, which provides our European customers with faster product delivery, improved visibility to the rapidly expanding eBioscience product portfolio, easy access to special bulk pricing and custom reagent development, as well as enhanced customer service and technical support levels. eBioscience would like to expand our worldwide footprint to include areas we are not well represented in, including Africa, Latin America, South America, and the Middle East. We have over 10,000 RUO products for sale. Therefore, we are looking to add distributors in these areas.
Ellman International
Oceanside, New York - www.ellman.com
- Ellman is a New York-based manufacturer of high-frequency/low temperature precision radiowave technology for use in all soft tissue surgery, established in 1959.
- The Surgitron equipment provides the surgeon with the ability to finely cut and coagulate tissue through the use of high frequency radiowaves. The Ellman Surgitron models are the only instruments worldwide that provide a pure radio frequency of 4MHz which has been clinically proven to cause less than 20 microns of thermal tissue alteration. This technology produces the highest quality and fastest healing results.
- Ellman International has a network of over 70 distribution partners worldwide in countries such as Norway, Netherlands, Belgium, Denmark, Finland, Hungary, Spain, Italy, Portugal, and Turkey. Ellman is seeking additional partners who represent 10 or less manufacturers and have at least $1M in annual turnover, in additional markets such as Saudi Arabia and Australia.
FDA - U.S. Food and Drug Administration
Rockville,
Maryland - www.fda.gov
- FDA regulates a host of products, from the most common food
ingredients to complex medical and surgical devices, lifesaving
drugs, and radiation-emitting consumer and medical products.
These products are worth about a trillion dollars a year and make
up 25% of all consumer spending.
Most of the Agency’s nearly 10,000 employees are scientists, consumer safety officers, medical officers, and other professionals.
A member of the FDA will be present at MEDICA to assist and counsel U.S. and other firms on FDA regulations and certification procedures.
Laser Peripherals, LLC
Minneapolis, Minnesota -
www.laserperipherals.com
- Laser Peripherals designs, manufactures, distributes and OEM’s medical laser fibers for use in both hard and soft tissue surgical laser applications. We manufacture and market at least thirty different surgical fiber options for use with Diode, Holmium, KTP and Nd:YAG lasers. Fiber designs include free-beam, contact and lateral emitting. Laser Peripherals has recently completed our ISO/CE certification and we are now actively looking for distribution partners in a variety of international markets.
- We would like to establish contacts and with business partners and find distributors from Germany, France and Spain in particular.
Luminetx Corporation
Memphis, Tennessee - www.luminetx.com
- The VeinViewer, Luminetx’ signature product, is a vascular imaging system that allows physicians, nurses and other health care professionals to clearly see accessible vasculature (or lack thereof) in real time. The device uses a combination of near-infrared light and patented technologies to image vascular structures and projects their location directly on the surface of the skin. This provides clinicians with a safe, non-invasive adjunct technology for clinical treatments and procedures including, but not limited to: IV insertions, PICC line insertions, routine venipuncture (blood sampling), blood and plasma donations and treatment for varicose and spider veins. In effect we can reduce the time to start an IV by 50%, reduce the number of Needlestick attempts by 50%, improve patient care 2x and avoid unnecessary more serious and infection-related procedures such as PICC and Central Lines. VeinViewer is the world leader in near-surface vascular imaging and access with over 1200 units placed currently selling into over 40 countries.
- Target Markets: Primary care hospitals. Secondary markets include aesthetics for vein removal and blood/plasma markets.
- Certifications: Class 1 exemptk we have ISO and CE marks.
- Call points/types of distribution that would match well with VeinViewer: medical capital equipment; medical vascular access consumables; vascular access medical; medical device focused on vascular, oncology, urology, radiology, pediatric, neonatal, laboratory, blood or plasma, and laboratory. Experience in medical sales with proven track record of selling products that require a capital equipment budget of some kind, product portfolio small enough to allow focus, proven ability to develop market with a new product, good references from existing manufacturers, ability to perform to contract, focus on patient care, proven ability to both sell and service equipment, proven ability to follow and meet regulatory needs.
LuxteL LLC
Danvers, Massachusetts - www.luxtel.com
- LuxteL designs and manufactures a core technology product line of specialty xenon ceramic lamps and accessories trademarked CeraLux® and a vertically integrated range of medical lighting products which include surgical headlights, fiberoptic illuminators and video cameras trademarked IsoluX®. The resultant products are more rugged, offer better color rendition and eliminate environmental concerns associated with other lighting techniques.
- At MEDICA we would like to establish business contacts with representatives from Germany, Austria and Italy in particular.
Methodize Inc.
Oak Grove, Minnesota - www.methodizeinc.com
- With over 35 years of combined Regulatory, Quality and Clinical services, Methodize has been helping companies all over the world in bringing medical devices and In-Vitro Diagnostics products to market. Anyone can read the regulations; we provide efficient and effective solutions. Our services also ensure that post market compliance is maintained through labeling advice and compliance with the applicable regulations. Whether you are pondering the most effective way of pursuing a regulatory submission, starting up a clinical trial or need to meet a quality system regulation or international standard, Methodize is the one to call.
- Methodize is looking for customers in Germany, France and Spain in particular.
Missouri Partnership
St. Louis, Missouri - www.missouripartnership.com
- The Missouri Partnership is an investment promotion agency focused on recruiting new private sector investment to Missouri from both domestic and international corporations.
- Missouri is located in the Midwest and is consistently ranked as one of the top US business states. It is ranked #1 for Manufacturing & Logistics, #4 for lowest Business Costs and #5 for lowest Cost of Living.
- The Missouri Partnership is particularly interested in establishing contacts with potential customers in Germany, France and the United Kingdom.
NuStep, Inc.
Ann
Arbor, Michigan - www.nustep.com
- Headquartered in Ann Arbor, Mich., NuStep, Inc. is an ISO 9001 registered manufacturer of the award winning NuStep Recumbent Cross Trainers. These patented machines were developed by exercise physiologists to help people stay in motion regardless of physical condition. NuStep's products are used at hospitals, rehabilitation centers and fitness centers around the world, including the Mayo Clinic, Beijing Hospital, Toronto Rehabilitation Institute, the Cleveland Clinic and the Duke Center for Living. Our products carry the CE mark, and have won several Innovation and Design Excellence awards. We are looking for channel partners around the world to help extend our presence internationally. Please visit with us to discuss opportunities to work together in your region. We are particularly interested in finding distributors in Germany, the United Kingdom, and France.
Step Forward Orthotics
Kent, Washington - www.stepforward.com.au
- Step Forward Orthotics, made in Seattle since 1974, are flexing arch supports which re-align the body and strengthen the muscles in the feet. The system of sizing and fitting is easily taught – you do not need to be a doctor! They are sold direct to the public and also through a network of doctors, physiotherapists, chiropractors and other therapists. We seek national distributors for many countries, with primary focus on Europe, especially Germany. All enquiries welcome.
STI Medical Systems
Honolulu, Hawaii - www.sti-medical.com
- The CervicalMD™ instrument is an intelligent high-definition digital colposcope. The system runs real-time quality assessment algorithms, displays video and still images during or after an examination, and allows for seamless annotation and patient records management. The product will be CE-marked shortly and STI Medical is seeking distributors in Europe and the world, in particular in Germany, the Netherlands, and the United Kingdom.
Timely Medical Innovations, LLC
Carlsbad, California - www.timelymedical.com
- Since 1991 TMI has been designing and marketing low-cost, disposable products to enable healthcare professionals to comply with regulatory standards for infection control. TMI products provide face and eye protection for procedures with a potential for splashing, spraying or splattering of blood or other potentially infectious materials. For 15+ years, these low-cost, comfortable and disposable products have been a popular choice among healthcare providers.
- Known for its product innovation, TMI's most recent patents include the Resposables™ products for eye protection (EyeShield™) and full-face protection (FaceShield™). These EU-certified products have a unique modular design, reusable frames and disposable optical grade lenses. TMI's renowned products are promoted by a worldwide channel of medical products distributors and supported by TMI marketing services such as product-branding, product samples, co-marketing, trade show support, collateral materials and more.
Typenex Medical LLC
Chicago, Illinois - www.typenex.com
- Typenex Medical is a medical device company focused on transfusion safety products, specifically blood recipient verification wristbands.
- In global markets, we would like to promote:
our various blood recipient verification wristbands, which are used to ensure that the right blood is given to the right recipient and our in-vitro diagnostic device that is used in cross-matching procedures in blood banks - We would like to meet potential partners from all over the EU, particularly Spain, Ireland, and Germany. Expansion into Canada, Australia, New Zealand, and Japan is of interest for us as well though.
UL International Germany GmbH
Neu-Isenburg - www.UL-Europe.com
- Underwriters Laboratories® (UL) is an independent product safety certification organization that has been writing Standards for Safety, testing products and involved in conformity assessment for well over a century. UL evaluates more than 19,500 types of products, components, materials and systems annually with 20 billion UL Marks appearing on 72,000 manufacturers’ products in the global marketplace each year. UL’s worldwide family of companies and network of service providers includes 64 laboratory, testing and certification facilities serving customers with business operations on six continents.
- Underwriters Laboratories is a leading provider of end-to-end regulatory, certification, and registration services for the medical industry. Through our portfolio of global accreditations, our customers have access to all the major medical device markets. In addition to certification testing on UL/IECE 60601 and IECE 60601, our services include: FDA 510(k) third-party reviews for the U.S., MDD/IVDD Notified Body certification for Europe, CB scheme certification, INMETRO certification for Brazil, PAL third party for Japan, risk management registration to ISO 14971, and UL is a CMDCAS recognized registrar for Canada.
- As a recognized third party for the major medical market public health organizations, UL Health Sciences can facilitate the timing and predictability of your product launch so you have market access to multiple countries with one set of tests, one quality system audit, and one company evaluating conformance of your technical file. UL’s leadership in the global industry is evidenced in the fact that UL has reviewed more 510(k)s under the FDA 3rd Party Program than any other Accredited Body and has issued more CB reports for the MED category in the IECEE CB Scheme than any other NCB.
- At MEDICA we are particularly interested in meeting global manufacturers of medical devices and IVDs that are exporting to the U.S., the EU, Japan, Brazil, Canada, Taiwan, Australia, and China. For more information visit: www.ul.com/medical.