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Address: Am Anger 27, Bernau 83233, Germany
www.dekumed.de |
Send Inquiry |
Phone: +49-(8051)-967 33
FDA Registration: 9616533
Products: External Breast Prosthesis (FDA Code:
KCZ), ...
Dekumed Gmbh supplies breast prostheses. Classique and Mystique are the models of our external breast prostheses provided with adhesive.
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Address: 23, Grafenstr, Brannenburg 83098, Germany
Phone: +49-(803)-4301333
FDA Registration: 9680655
Products: External Breast Prosthesis (FDA Code:
KCZ), ...
Anita Dr. Helbig Gmbh & Co. specializes in providing breast prostheses.
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Address: Koenigsreihe 22, Hamburg 22041, Germany
www.medimex.de |
Send Inquiry |
Phone: +49-(40)-6588-6500
Employee Count: ~50
Quality: ISO 9001 Certified
Products: Surgical Gloves, Powder-Free Latex Surgical Gloves, Powdered Exam Gloves and Latex Surgical Gloves, Synthetic Surgical Gloves, Powder-Free Synthetic Surgical Gloves, Latex Free Sterile Surgical Gloves, ...
Medimex Gmbh & Co. Kg offers plastic oxygen masks, bacteria and virus filters, and epidural kits and trays.
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Address: Kollaustr. 6, Hamburg 22529, Germany
www.steco.de |
Send Inquiry |
Phone: +49-(40)-5577810
FDA Registration: 9617660 Quality: EN ISO 13485:2003 and EN ISO 9001:2000 Certified
Products: Non-invasive Magnetic Stimulation System, Dental Implants, Facial Prostheses, External Breast Prosthesis (FDA Code:
KCZ), ...
Steco-System-Technik Gmbh & Co. Kg focuses on dental implantation and facial prostheses. We provide Steco® and Titanmagnetics® magnets. These magnets are encased in corrosion-resistant titaniu
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Address: Subdivision Reybaud, Saignon 84400, France
Phone: +33-(4)-90746763
Products: External Breast Prosthesis (FDA Code:
KCZ), ...
Sodipromm Sarl provides external breast forms.
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Address: Holtedam 1, Humlebaek DK-3050, Denmark
www.coloplast.com |
Send Inquiry |
Phone: +45-(0)-4911-1111
FDA Registration: 9610694 Year Established: 1957
Annual Revenues: USD 100-500 Million
Employee Count: ~7000
Quality: CE Certified
Products: Urethral Catheters (FDA Code:
GBM), Urine Collection Leg Bags (FDA Code:
FAQ), Straight Catheter (FDA Code:
EZD), Urological Catheters (FDA Code:
KOD), Penile Prosthesis (FDA Code:
FAE), Sterile Leg Urine Collection Bag for External Use (FDA Code:
FAQ), ...
Coloplast A/S develops products and services that make life easier for people with very personal & private medical conditions. Our business includes ostomy care, urology & continence care, and wound &
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Address: 189 Colonnade Rd., South, Nepean, Ontario K2E 7J4, Canada
www.airwaysurgical.ca |
Send Inquiry |
Phone: +1-(800)-267-3476
FDA Registration: 9611956
Products: Elastic Bandages (FDA Code:
FQM), Urinals (FDA Code:
FNP), Arm Slings (FDA Code:
ILI), Traction Accessories, Leg Straps (FDA Code:
ILZ), Abdominal Binders (FDA Code:
FSD), Cervical Thoracic Orthosis (FDA Code:
IPT), ...
Airway Surgical Appliances Ltd. manufactures health care products. Our products include compression hosieries, supports, splints, braces, home medical supplies & equipments, airway mastectomy products
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FDA Code / Regulation: KCZ / 878.3800 An external aesthetic restoration prosthesis is a device intended to be used to construct an external artificial body structure, such as an ear, breast, or nose. Usually the device is made of silicone rubber and it may be fastened to the body with an external prosthesis adhesive. The device is not intended to be implanted.
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in 878.9. If the device is intended for use without an external prosthesis adhesive to fasten it to the body, the device is exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of 820.180, with respect to general requirements concerning records, and 820.198, with respect to complaint files.