AndoFlex Zinc Single
by Andover Healthcare Inc. EUDAMED
Active
Ref ASP-UB830Z-01Model AndoFlex Zinc Single
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR | Number0724004AndFlxZNSNGLMY | Date15 Apr 2026 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
European Union — CE/MDR Active
Certificates
No notified-body certificate is listed. Devices of this class are self-declared by the manufacturer.
Specification
- Device Name
- Coflex Tlc
- Model / Reference
- AndoFlex Zinc Single, ASP-UB830Z-01
- Primary DI / UDI-DI
- 00724004620919
- Basic UDI-DI
- 0724004AndFlxZNSNGLMY
- 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
Other properties (11)
- Sterile: No
- Implantable: No
- Reusable: No
- Contains Latex: No
- Reprocessed: No
- CMR Substance: No
- Human-derived: No
- Human Tissues: No
- Endocrine Disruptor: No
- Administering Medicine: No
- Measuring Function: No