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AndoFlex Calamine Single
EUDAMEDClass I (EU MDR)
Ref ASP-UB840C-01Model AndoFlex Calamine SingleRef ASP-UB830C-01
Identity
- Trade Name
- AndoFlex Calamine Single EUDAMED
- Device Name
- COFLEX TLC EUDAMED
- Model / Reference
- AndoFlex Calamine Single EUDAMEDASP-UB840C-01 EUDAMEDASP-UB830C-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00724004620926 EUDAMED00724004620902 EUDAMED
- Basic UDI-DI
- 0724004AndoFlexCALSNGLXU EUDAMED
- EMDN Code
- M03040299 ELASTIC SUPPORT BANDAGES - OTHER EUDAMEDM030402020101 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 Calamine Single 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 | 0724004AndoFlexCALSNGLXU | 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 6cec5819-c65b-4ea4-8fba-705b1ceca7d5 61 fields · synced Oct 6, 2026
- EUDAMED 907e9862-3e64-4434-976b-0f6acc0718ae 61 fields · synced Jul 26, 2026