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Coolprene Wrist Support With Thumb Stabilizer
EUDAMEDClass I (EU MDR)
Ref 763CN-BL-XLRef 763CN-TAN-XLRef 763CN-BL-MRef 763CN-TAN-LRef 763CN-BL-SRef 763CN-BK-XLRef 763CN-BK-L
Identity
- Trade Name
- COOLPRENE WRIST SUPPORT WITH THUMB STABILIZER EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 763CN-BL-XL EUDAMED763CN-TAN-XL EUDAMED763CN-BL-M EUDAMED763CN-TAN-L EUDAMED763CN-BL-S EUDAMED763CN-BK-XL EUDAMED763CN-BK-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269527050 EUDAMED00840269527098 EUDAMED00840269527036 EUDAMED00840269527081 EUDAMED00840269527029 EUDAMED00840269527012 EUDAMED00840269527005 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 (7)
- EUDAMED 89f45d0f-03bd-47f3-9169-28c7ac13c7ec 61 fields · synced Jul 27, 2026
- EUDAMED 0624937b-b019-4cea-9c58-0cbd17528786 61 fields · synced May 17, 2026
- EUDAMED b5e70c00-1dc5-414d-a7fb-a9c74622a55a 61 fields · synced May 18, 2026
- EUDAMED 70fd2040-9c8b-4537-b517-41187cfb5b30 61 fields · synced May 18, 2026
- EUDAMED fe3a2b63-2f3b-4beb-9f79-447826c689e7 61 fields · synced May 18, 2026
- EUDAMED 367383be-8752-4772-8251-901c6eb8e8b5 61 fields · synced May 18, 2026
- EUDAMED 245097a7-7e43-4420-939d-b1180602b14c 61 fields · synced May 19, 2026