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CoFlex TLC Calamine
EUDAMEDClass I (EU MDR)
Ref 8830UBC-TN-INTLModel CoFlex TLC CalamineRef 8840UBC-SC-INTLModel CoFlex TLC Calamine Standard
Identity
- Trade Name
- CoFlex TLC Calamine EUDAMEDCoFlex TLC Calamine Standard EUDAMED
- Device Name
- COFLEX TLC EUDAMED
- Model / Reference
- CoFlex TLC Calamine EUDAMED8830UBC-TN-INTL EUDAMEDCoFlex TLC Calamine Standard EUDAMED8840UBC-SC-INTL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00724004611818 EUDAMED00724004619883 EUDAMED
- Basic UDI-DI
- 0724004CoFlexTLCCalaminUJ EUDAMED0724004COFLEXTLCCALSTDBE 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 Calamine 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 | 0724004CoFlexTLCCalaminUJ | 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 (2)
- EUDAMED 4184c6ed-4c93-4805-bdf5-229e9ca4f1ad 61 fields · synced Oct 6, 2026
- EUDAMED 009965a3-3819-4059-935b-0557e9b69fec 61 fields · synced May 18, 2026