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COLTRIX® CartiRegen, Collaju®
EUDAMEDClass III (EU MDR)
Ref UBS-TCF-01-01
by Ubiosis
Identity
- Device Name
- COLTRIX® CartiRegen, Collaju® EUDAMED
- Model / Reference
- UBS-TCF-01-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800033900108 EUDAMED
- Basic UDI-DI
- B-08800033900108 EUDAMED
- EMDN Code
- V9099 VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Device sterilization/disinfection container, reusable
COLTRIX® CartiRegen, Collaju® by Ubiosis — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800033900108 | Class III | Active |
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Manufacturer
- Manufacturer
- Ubiosis
- EUDAMED SRN
- KR-MF-000028123
- Authorised Representative
- AeMi World e.K DE-AR-000007704
Sources (1)
- EUDAMED bb4f6edc-ff6f-4fb9-9daf-79a40213c5a6 61 fields · synced Jun 18, 2026