Identity
- Trade Name
- COFLEX AFD EUDAMED
- Device Name
- COFLEX EUDAMED
- Model / Reference
- CoFlex AFD EUDAMED9740TN-08 EUDAMED9720TN-016 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00724004607088 EUDAMED00724004607101 EUDAMED
- Basic UDI-DI
- 0724004CoFlexAFD7H EUDAMED
- EMDN Code
- M030402020101 ELASTIC SUPPORT BANDAGES, COHESIVE, EXTENSIBLE IN ONE DIRECTION, HIGH EXTENSIBILITY EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
Yes
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Coflex Afd by Andover Healthcare Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Manufacturer's product page: CoFlex® AFD
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 0724004CoFlexAFD7H | Class I | Active |
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Manufacturer
- Manufacturer
- Andover Healthcare Inc.
- EUDAMED SRN
- US-MF-000035055
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (3)
- EUDAMED 11d7d637-5d98-4fd0-a011-edb38d04c826 61 fields · synced Oct 6, 2026
- EUDAMED 18f85c83-9821-47e0-b44b-2e4172d0f1d6 61 fields · synced Jul 14, 2026
- EUDAMED 62bdb63e-d572-42bf-bd70-45241502bb07 61 fields · synced Jul 18, 2026