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Splint Wrist Brace
EUDAMEDClass I (EU MDR)
Ref 904-L-TAN-MRef 904-L-TAN-SRef 904-L-TAN-LRef 904-R-TAN-SRef 904-L-TAN-XL
Identity
- Trade Name
- Splint Wrist Brace EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 904-L-TAN-M EUDAMED904-L-TAN-S EUDAMED904-L-TAN-L EUDAMED904-R-TAN-S EUDAMED904-L-TAN-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269535291 EUDAMED00840269535277 EUDAMED00840269535314 EUDAMED00840269535260 EUDAMED00840269535338 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
Splint Wrist Brace 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 2fa831de-8af2-4288-a2e3-38e56b11a414 61 fields · synced Aug 2, 2026
- EUDAMED 620aa64b-5008-4d86-a9a7-ea379e40a9e7 61 fields · synced May 17, 2026
- EUDAMED 4be2ee2e-c18a-4d0c-8a1f-73379633d0c8 61 fields · synced May 18, 2026
- EUDAMED 847ca028-3811-4c97-a5ac-3def8f23f6e6 61 fields · synced May 19, 2026
- EUDAMED ce154690-b49e-4c9b-bf30-0b9c6b83b8fd 61 fields · synced May 19, 2026