← Back to catalogue
Wrist Brace
EUDAMEDClass I (EU MDR)
Ref 552-L-BK-XLRef 552-L-BK-LRef 552-R-BK-XLRef 552-R-BK-SRef 552-R-BK-L
Identity
- Trade Name
- Wrist Brace EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 552-L-BK-XL EUDAMED552-L-BK-L EUDAMED552-R-BK-XL EUDAMED552-R-BK-S EUDAMED552-R-BK-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269510922 EUDAMED00840269510908 EUDAMED00840269510915 EUDAMED00840269510854 EUDAMED00840269510892 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
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 |
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 (5)
- EUDAMED c5d56f08-f4f2-48e1-8228-530cbd997190 61 fields · synced Jul 26, 2026
- EUDAMED 10f89e1a-1551-4a72-baea-e693f68e1cb3 61 fields · synced May 17, 2026
- EUDAMED 073cb491-0cce-4b40-8eac-3e37c03c3f78 61 fields · synced May 18, 2026
- EUDAMED 88c447be-1a05-49ad-a994-e1b5ca7dac2d 61 fields · synced May 18, 2026
- EUDAMED 8a015bf9-b5b3-459d-8806-41c5e75716e3 61 fields · synced May 18, 2026