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COOLPRENE X Wrist Support
EUDAMEDClass I (EU MDR)
Ref FT35CA-BK-FRef 563CAR1-BK-F
Identity
- Trade Name
- COOLPRENE X Wrist Support EUDAMEDCOOLPRENE X Wrist Support with Thumb Stabilizer EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- FT35CA-BK-F EUDAMED563CAR1-BK-F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269506963 EUDAMED00840269504150 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 X Wrist Support 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 (2)
- EUDAMED 95564cac-7781-4914-a6c3-bc85261ac677 61 fields · synced Jul 17, 2026
- EUDAMED 1f4a3fab-9e3b-454d-b60f-7f5f40c739fb 61 fields · synced May 19, 2026