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Wrist Splint
EUDAMEDClass I (EU MDR)
Ref 535CP-L-BK-XLRef 725-R-TAN-SRef 725-R-BL-MRef 725-R-BL-LRef 725-R-BL-XLRef 725-L-BK-XSRef 725-R-BK-XLRef 725-R-BK-MRef 535CP-R-BK-SRef 725-L-BL-SRef 725-L-BL-XSRef 725-L-BL-MRef 725-L-TAN-SRef 535CP-R-BK-LRef 535CP-R-BK-XLRef 725-R-TAN-LRef 725-L-BK-LRef 521CA-L-BK-FRef 725-R-TAN-XLRef 725-L-BK-MRef 725-L-BK-SRef 725-R-BK-SRef 725-R-BL-XSRef 725-R-TAN-XS
Identity
- Trade Name
- Wrist Splint EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 535CP-L-BK-XL EUDAMED725-R-TAN-S EUDAMED725-R-BL-M EUDAMED725-R-BL-L EUDAMED725-R-BL-XL EUDAMED725-L-BK-XS EUDAMED725-R-BK-XL EUDAMED725-R-BK-M EUDAMED535CP-R-BK-S EUDAMED725-L-BL-S EUDAMED725-L-BL-XS EUDAMED725-L-BL-M EUDAMED725-L-TAN-S EUDAMED535CP-R-BK-L EUDAMED535CP-R-BK-XL EUDAMED725-R-TAN-L EUDAMED725-L-BK-L EUDAMED521CA-L-BK-F EUDAMED725-R-TAN-XL EUDAMED725-L-BK-M EUDAMED725-L-BK-S EUDAMED725-R-BK-S EUDAMED725-R-BL-XS EUDAMED725-R-TAN-XS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269511776 EUDAMED00840269518829 EUDAMED00840269518874 EUDAMED00840269518935 EUDAMED00840269518997 EUDAMED00840269518799 EUDAMED00840269518980 EUDAMED00840269518867 EUDAMED00840269505874 EUDAMED00840269518843 EUDAMED00840269518782 EUDAMED00840269518904 EUDAMED00840269518836 EUDAMED00840269509711 EUDAMED00840269509988 EUDAMED00840269518942 EUDAMED00840269518973 EUDAMED00840269535345 EUDAMED00840269519000 EUDAMED00840269518911 EUDAMED00840269518850 EUDAMED00840269518805 EUDAMED00840269518744 EUDAMED00840269518768 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 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 (24)
- EUDAMED d29d6f64-9748-4c64-ad6c-74c6e9a1326a 61 fields · synced Aug 4, 2026
- EUDAMED 7f61344c-97ea-4574-8d48-46f016616193 61 fields · synced May 17, 2026
- EUDAMED ccb22c35-d0da-40c6-9a24-14120bbf68ba 61 fields · synced May 17, 2026
- EUDAMED e1a3904b-6b88-429c-9c0f-cc55163a739a 61 fields · synced May 17, 2026
- EUDAMED 943b1a89-7601-4546-aa7f-365f6d667244 61 fields · synced May 17, 2026
- EUDAMED 03f4c4b3-4898-4bba-b696-dd8d9226aac6 61 fields · synced May 17, 2026
- EUDAMED 4bb4e4ee-8c82-445a-95c0-64191faf5f4c 61 fields · synced May 17, 2026
- EUDAMED 0aec38de-4c28-4cad-b5c2-757a43726277 61 fields · synced May 17, 2026
- EUDAMED 60a4d0e6-5881-40ce-b4e9-5c83fa596982 61 fields · synced May 17, 2026
- EUDAMED 22362a32-1e14-4cbc-b984-df6da191c016 61 fields · synced May 17, 2026
- EUDAMED 6a6ebd8a-c83a-4194-a7a1-fab746b40d6b 61 fields · synced May 17, 2026
- EUDAMED 65fb7eca-f70d-4a14-addf-454a836d4062 61 fields · synced May 17, 2026
- EUDAMED bc8d52f7-7c88-4099-acc6-cd4d873b2c7f 61 fields · synced May 17, 2026
- EUDAMED d19d835d-8f68-492c-8b84-c0e0067ac35c 61 fields · synced May 18, 2026
- EUDAMED 714492f5-5db3-4c2c-8ce2-5ed03f917e2a 61 fields · synced May 18, 2026
- EUDAMED 7c75bc25-f82c-42a2-acfb-410f36068ec2 61 fields · synced May 18, 2026
- EUDAMED b5447f6e-5835-4bfe-8bff-e52361ac2d7d 61 fields · synced May 18, 2026
- EUDAMED f42da887-0ea2-40b5-96ac-a1a86dde3da5 61 fields · synced May 18, 2026
- EUDAMED ee351cca-4e94-4047-a6d5-dea59a74fcc3 61 fields · synced May 18, 2026
- EUDAMED 994e89c5-a875-4aed-83ad-d7b2c8615ab3 61 fields · synced May 18, 2026
- EUDAMED 968450f3-5568-42b4-9690-37e585f9a7f5 61 fields · synced May 18, 2026
- EUDAMED 29bd485a-8636-430d-b8f5-9fa5d2b9d6c1 61 fields · synced May 18, 2026
- EUDAMED 1207672c-9ec2-4c1a-864f-f7c4c20a657d 61 fields · synced May 18, 2026
- EUDAMED 2d4765e9-49e8-4780-9be2-cc132c29bfd4 61 fields · synced May 19, 2026