← Back to catalogue
CoFlex TLC Zinc Standard
EUDAMEDClass I (EU MDR)
Ref 8840UBZ-SC-INTLModel CoFlex TLC Zinc Standard
Identity
- Trade Name
- CoFlex TLC Zinc Standard EUDAMED
- Device Name
- COFLEX TLC EUDAMED
- Model / Reference
- CoFlex TLC Zinc Standard EUDAMED8840UBZ-SC-INTL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00724004619890 EUDAMED
- Basic UDI-DI
- 0724004COFLEXTLCZNSTDDY EUDAMED
- EMDN Code
- M03040299 ELASTIC SUPPORT BANDAGES - OTHER 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
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
Yes
EUDAMED
CoFlex TLC Zinc Standard 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 | 0724004COFLEXTLCZNSTDDY | Class I | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Andover Healthcare Inc.
- EUDAMED SRN
- US-MF-000035055
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED 81adedd7-0557-4b84-ac22-f6c07b1551ae 61 fields · synced Oct 7, 2026