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AndoFlex TLC Calamine Standard
EUDAMEDClass I (EU MDR)
Ref ASP-8830UBC-SCModel AndoFlex TLC Calamine Standard
Identity
- Trade Name
- AndoFlex TLC Calamine Standard EUDAMED
- Device Name
- AndoFlex TLC EUDAMED
- Model / Reference
- AndoFlex TLC Calamine Standard EUDAMEDASP-8830UBC-SC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00724004621206 EUDAMED
- Basic UDI-DI
- 0724004AndFlxTLCCALSTDW7 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
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
AndoFlex TLC Calamine 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 | 0724004AndFlxTLCCALSTDW7 | 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 7516e7a8-be05-4088-843c-68a40b4efb34 61 fields · synced Jun 19, 2026