Identity
- Trade Name
- PowerFlex 5yard EUDAMED
- Device Name
- COFLEX EUDAMED
- Model / Reference
- PowerFlex 5yard EUDAMED3815WH-048 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00724004385078 EUDAMED
- Basic UDI-DI
- 0724004PowerFlex5yardAX 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
PowerFlex 5yard by Andover Healthcare Inc. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 0724004PowerFlex5yardAX | 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 (1)
- EUDAMED fbb084b5-b1da-40a3-8b43-f85894ddfe0b 61 fields · synced Jul 20, 2026