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COOLPRENE X Wrist Brace with Double Splints
EUDAMEDClass I (EU MDR)
Ref 725CA-R-BK-S-CCRef 725CA-L-BK-L-CCRef 725CA-L-BK-XL-CCRef 725CA-L-BK-S-CCRef 725CA-R-BK-XL-CC
Identity
- Trade Name
- COOLPRENE X Wrist Brace with Double Splints EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 725CA-R-BK-S-CC EUDAMED725CA-L-BK-L-CC EUDAMED725CA-L-BK-XL-CC EUDAMED725CA-L-BK-S-CC EUDAMED725CA-R-BK-XL-CC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269510540 EUDAMED00840269510663 EUDAMED00840269510670 EUDAMED00840269510588 EUDAMED00840269510571 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 Brace with Double Splints 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 (5)
- EUDAMED 5a0c8be4-6376-4960-95e3-6fb4d2b08983 61 fields · synced Sep 17, 2026
- EUDAMED ca2c77d1-471d-46e7-98c6-1230341ef956 61 fields · synced May 16, 2026
- EUDAMED 30ac1e1f-a76a-45aa-a3b3-6e3e205d8b90 61 fields · synced May 17, 2026
- EUDAMED 35bccd0e-c8df-4c6e-b9e1-67cedce05f71 61 fields · synced May 18, 2026
- EUDAMED fe754568-2af9-4ad3-8a06-c4050a6f47ba 61 fields · synced May 19, 2026