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Coolprene Wrist Brace With Palmar Splint
EUDAMEDClass I (EU MDR)
Ref 725CN-R-BL-SRef 725CN-R-BK-SRef 725CN-L-BK-MRef 725CN-R-BL-MRef 725CN-L-TAN-LRef 725CN-L-TAN-SRef 725CN-R-TAN-MRef 725CN-R-TAN-XLRef 725CN-L-TAN-XLRef 725CN-L-BK-LRef 725CN-L-BK-SRef 725CN-L-BL-S
Identity
- Trade Name
- COOLPRENE WRIST BRACE WITH PALMAR SPLINT EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 725CN-R-BL-S EUDAMED725CN-R-BK-S EUDAMED725CN-L-BK-M EUDAMED725CN-R-BL-M EUDAMED725CN-L-TAN-L EUDAMED725CN-L-TAN-S EUDAMED725CN-R-TAN-M EUDAMED725CN-R-TAN-XL EUDAMED725CN-L-TAN-XL EUDAMED725CN-L-BK-L EUDAMED725CN-L-BK-S EUDAMED725CN-L-BL-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269526626 EUDAMED00840269526572 EUDAMED00840269526435 EUDAMED00840269526633 EUDAMED00840269526541 EUDAMED00840269526527 EUDAMED00840269526688 EUDAMED00840269526718 EUDAMED00840269526558 EUDAMED00840269526442 EUDAMED00840269526428 EUDAMED00840269526473 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 Brace With Palmar Splint 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 (12)
- EUDAMED 916b5f9f-ad90-4dc6-80a8-8ca440810b0d 61 fields · synced Sep 18, 2026
- EUDAMED 9754810d-267f-42c7-9f64-ed1843dabeb7 61 fields · synced May 16, 2026
- EUDAMED 6ac8115a-624c-4a81-82ef-485ca45d56ad 61 fields · synced May 16, 2026
- EUDAMED 8f3eb2fe-8522-4658-a3e7-49400e39bc62 61 fields · synced May 16, 2026
- EUDAMED 7210cf89-1ca3-41a6-bfca-226b6934f0fc 61 fields · synced May 17, 2026
- EUDAMED d7f6d327-df1d-4d5c-a57f-cd2e66926821 61 fields · synced May 17, 2026
- EUDAMED 878d8ca5-fc70-4881-a346-4bef23176a25 61 fields · synced May 17, 2026
- EUDAMED 9fd418ae-f348-4514-830e-8a7ac0d92bb7 61 fields · synced May 17, 2026
- EUDAMED 43458bb7-284a-47ad-9799-116cf453f87a 61 fields · synced May 18, 2026
- EUDAMED 7095814a-3a0a-45a6-bfc9-4f2a8286c6ad 61 fields · synced May 18, 2026
- EUDAMED 281d4f24-dc4c-47ec-b91a-8b7bf23f4407 61 fields · synced May 18, 2026
- EUDAMED bb5b44fb-34f8-4f0e-8b6d-1f0d1952c02c 61 fields · synced May 19, 2026