PowerFlex 5yard
by Andover Healthcare Inc. United States EUDAMED
Ref 3815BL-048Model PowerFlex 5yard
EMDN M030402020101
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0724004PowerFlex5yardAX | Date27 Mar 2026 | StatusActive |
Coverage
- Active
- Not covered
European Union — CE/MDR Active
Specification
- Device Name
- Coflex
- Model / Reference
- PowerFlex 5yard, 3815BL-048
- Primary DI / UDI-DI
- 00724004385016
- Basic UDI-DI
- 0724004PowerFlex5yardAX
- EMDN Code
- M030402020101 Elastic support bandages, cohesive, extensible in one direction, high extensibility
- Device Class
- Class I
- Market of Registration
- Denmark
Manufacturer details
- EUDAMED SRN
- US-MF-000035055
- Authorised representative
- Advena Limited MT-AR-000000234
Other devices from Andover Healthcare Inc.
Properties & raw data
Show properties, registry sources and raw records
Other properties (12)
- Sterile: No
- Implantable: No
- Reusable: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Animal Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No
- Incorporates Medicinal Product: No
Sources (1)
- EUDAMED 4516e854-967c-4864-a69d-b717bb4259d0