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Sign in to claim this brandAMD Medicom Inc
US
Last updated May 24, 2026
What AMD Medicom Inc makes
AMD Medicom Inc manufactures single-use medical textiles and protective barriers, including surgical and isolation gowns, non-antimicrobial face masks, and nitrile examination gloves. Their portfolio also includes sterilization packaging, radiopaque surgical sponges, and various gauze pads for wound care and procedural use.
The company’s products are regulated under FDA’s Class I and Class II categories, with some devices classified as unlisted (U). These items are listed in the FDA’s Unique Device Identifier (UDI) database, ensuring traceability and compliance with U.S. medical device regulations.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does AMD Medicom Inc manufacture?
AMD Medicom Inc specializes in single-use medical textiles and protective barriers. Their product range includes surgical and isolation gowns, non-antimicrobial face masks, nitrile examination gloves (non-powdered), sterilization packaging, radiopaque surgical sponges, and various gauze pads for wound care and procedural use. These items are designed for clinical, surgical, and examination settings to ensure patient and staff safety.
Where is AMD Medicom Inc based?
AMD Medicom Inc is headquartered in the United States. While the exact location isn’t specified, the company operates within the U.S. regulatory framework, which governs its medical device portfolio.
Which regulatory registries list AMD Medicom Inc’s devices?
AMD Medicom Inc’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry ensures traceability and compliance with U.S. medical device regulations by assigning a standardized identifier to each product, helping track devices throughout their lifecycle.
How are AMD Medicom Inc’s devices classified under U.S. regulations?
AMD Medicom Inc’s devices fall under FDA’s Class I and Class II categories, with some classified as unlisted (U). Class I devices generally pose minimal risk and require less regulatory oversight, while Class II devices involve a higher risk and require special controls to ensure safety and effectiveness. The unlisted (U) classification indicates devices not previously cleared or approved, requiring additional review.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- medicom.ca
- —
- —
- [email protected]
- Phone
- 1(514)636-6262
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 256880576
Catalogue (1527)
Page 30 of 31| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Generic | 551436 | FDA UDI | Class II | Active |
| Medicom AssureTouch | 9998-D | FDA UDI | Class I | Active |
| Amd-Ritmed Solon | 55900 | FDA UDI | Class I | Active |
| Medicom Safebasics | 40007 | FDA UDI | Class I | Active |
| Medicom SafeBasics | 80104 | FDA UDI | Class I | Active |
| Medicom Safeseal Quattro | 88040-4 | FDA UDI | Class II | Active |
| Generic | 551442PC | FDA UDI | Class II | Active |
| Medicom Safewear | 8118-B | FDA UDI | Class I | Active |
| Amd-Ritmed All Gauze | A3005 | FDA UDI | Class I | Active |
| Medicom Safemask N95 | M2321 | FDA UDI | Class II | Unknown |
| Amd-Ritmed All Gauze | B8125 | FDA UDI | Class I | Active |
| Medicom Safemask Freeflow | 200515 | FDA UDI | Class II | Active |
| Medicom Safewear | 8112-B | FDA UDI | Class I | Active |
| Tyvek Self-Seal Pouch | 560515 | FDA UDI | Class II | Active |
| Medicom Safewear | 8107-E | FDA UDI | Class I | Active |
| Medicom Safebasics | 3120 | FDA UDI | Class I | Unknown |
| Generic | 551015 | FDA UDI | Class II | Active |
| Ocean Pacific Intuition | OPM-IN | FDA UDI | Class I | Active |
| Amd-Ritmed Distech Stretch | D405 | FDA UDI | Class I | Active |
| Amd-Ritmed Distech | 2118 | FDA UDI | Class II | Unknown |
| Medicom Denticare | Swivel-SP3 | FDA UDI | Class I | Active |
| Ocean Pacific | OPM-BIO | FDA UDI | Class I | Active |
| Medicom Safebasics | 806 | FDA UDI | Class I | Active |
| Medicom AssureTouch | 9940-D | FDA UDI | Class I | Active |
| Amd-Ritmed All Gauze | B3009 | FDA UDI | Class I | Active |
| HedySeal Max Self-Sealing Sterilization Pouch | 610HSM-40 | FDA UDI | Class II | Active |
| Medicom AssureTouch | 1145-7 | FDA UDI | Class I | Active |
| Medicom AssureTouch | 9990-SP6 | FDA UDI | Class I | Active |
| Medicom Safewear Form Fit | 8113 | FDA UDI | Class I | Active |
| Medicom AssureTouch Noir | 9955D-SP10 | FDA UDI | Class I | Active |
| Medicom Distech | 7282 | FDA UDI | Class I | Active |
| Ocean Pacific Intuition | OPL-IN | FDA UDI | Class I | Active |
| Ocean Pacific | OPL-BIO | FDA UDI | Class I | Active |
| Medicom AssureTouch | 9985-C | FDA UDI | Class I | Active |
| Steril Peel | 222100 | FDA UDI | Class II | Active |
| Tyvek Heat-Seal Pouch | 550675 | FDA UDI | Class II | Active |
| Amd-Ritmed All Gauze | A2800 | FDA UDI | Class I | Active |
| Medicom Safewear | 8119-B | FDA UDI | Class I | Active |
| Medicom Safemask Freeflow | 200415 | FDA UDI | Class II | Active |
| Medicom Safegauze | 4522 | FDA UDI | Class I | Active |
| Medicom Safewear | 8102-C | FDA UDI | Class I | Active |
| Generic | 551215 | FDA UDI | Class II | Active |
| Elements by Hedy | HE-VPSMNF | FDA UDI | N/A | Unknown |
| Hedy SoftMask | 420HFW | FDA UDI | Class II | Active |
| Medicom AssureMask | 209918 | FDA UDI | Class II | Active |
| Steril Peel | 222102 | FDA UDI | Class II | Active |
| Medicom Safewear | 8118-D | FDA UDI | Class I | Active |
| Amd-Ritmed All Gauze | A3008 | FDA UDI | Class I | Unknown |
| Medicom Safebasics | 3001 | FDA UDI | Class I | Active |
| Amd-Ritmed All Gauze | B3005-4 | FDA UDI | Class I | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- AMD Medicom Inc. Pointe-Claire, Montreal Quebec · CA FEI 3002677549