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Breathable Wrist Brace
EUDAMEDClass I (EU MDR)
Ref 535-L-BK-LRef 535-R-BK-SRef 535-L-BK-MRef 535-R-BK-XL
Identity
- Trade Name
- Breathable Wrist Brace EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 535-L-BK-L EUDAMED535-R-BK-S EUDAMED535-L-BK-M EUDAMED535-R-BK-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269510472 EUDAMED00840269510427 EUDAMED00840269510458 EUDAMED00840269510489 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
Breathable 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 (4)
- EUDAMED 5d0f7070-627d-4d4a-8036-c9538b3a05f3 61 fields · synced Jul 25, 2026
- EUDAMED 10542a0b-6dec-42bc-9159-621770114291 61 fields · synced May 16, 2026
- EUDAMED 8c473565-3fbf-4e55-b654-0d7741ce8131 61 fields · synced May 18, 2026
- EUDAMED a96e7e3f-9c69-44de-b65b-6d38d74a6c6a 61 fields · synced May 18, 2026