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Coolprene Wrist Support With Thumb Stabilizer
EUDAMEDClass I (EU MDR)
Ref 763CN-BK-M
Identity
- Trade Name
- COOLPRENE WRIST SUPPORT WITH THUMB STABILIZER EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 763CN-BK-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269526992 EUDAMED
- Basic UDI-DI
- 08402695CL1038G EUDAMED
- EMDN Code
- Y060699 ORTHOSES, UPPER EXTREMITY - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Coolprene Wrist Support With Thumb Stabilizer by La Pointique Int´l Ltd. — 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 | 08402695CL1038G | Class I | Active |
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Manufacturer
- Manufacturer
- La Pointique Int´l Ltd.
- EUDAMED SRN
- US-MF-000005204
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (1)
- EUDAMED 6d716b4f-b109-47ff-ae1b-95b5eec3e023 61 fields · synced Jun 19, 2026