← Back to catalogue
Coolprene Wrist Support
EUDAMEDClass I (EU MDR)
Ref 703CN-BK-MRef 703CN-TAN-XLRef 703CN-TAN-SRef 703CN-BK-XLRef 703CN-BL-MRef 703CN-BL-LRef 703CN-BK-SRef 703CN-BK-L
Identity
- Trade Name
- COOLPRENE WRIST SUPPORT EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 703CN-BK-M EUDAMED703CN-TAN-XL EUDAMED703CN-TAN-S EUDAMED703CN-BK-XL EUDAMED703CN-BL-M EUDAMED703CN-BL-L EUDAMED703CN-BK-S EUDAMED703CN-BK-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269525544 EUDAMED00840269525667 EUDAMED00840269525636 EUDAMED00840269525568 EUDAMED00840269525599 EUDAMED00840269525605 EUDAMED00840269525537 EUDAMED00840269525551 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 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- La Pointique Int´l Ltd.
- EUDAMED SRN
- US-MF-000005204
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (8)
- EUDAMED 6dae338a-4fdc-4019-8b49-64d043e26680 61 fields · synced Jul 31, 2026
- EUDAMED ecf0e457-a300-4cb6-bf0d-ecaf9c4ad6dc 61 fields · synced May 17, 2026
- EUDAMED 436c74df-d6ec-41a2-a55a-6f70f0a88f0d 61 fields · synced May 17, 2026
- EUDAMED 394bfc3b-e7e4-43b6-9c5d-b2f5145c815b 61 fields · synced May 17, 2026
- EUDAMED 80da7614-80b9-4d27-bba1-8f8eb7e25504 61 fields · synced May 17, 2026
- EUDAMED 7b64f28e-2d60-40ae-a9ed-3f6f53aa4aaa 61 fields · synced May 18, 2026
- EUDAMED 482bc4e1-f9c5-4e4b-8d15-893dd317b245 61 fields · synced May 19, 2026
- EUDAMED 50b047db-cfc2-41dd-9336-e482214caa50 61 fields · synced May 19, 2026