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Elbow Brace for Tennis/Golf Elbow
EUDAMEDClass I (EU MDR)
Ref 551-BK-L-CCRef 551-BL-S-CCRef 551-BK-M-CCRef 551-BK-XL-CCRef 551-BL-L-CCRef 551-BK-S-CCRef 551-BL-XL-CC
Identity
- Trade Name
- Elbow Brace for Tennis/Golf Elbow EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 551-BK-L-CC EUDAMED551-BL-S-CC EUDAMED551-BK-M-CC EUDAMED551-BK-XL-CC EUDAMED551-BL-L-CC EUDAMED551-BK-S-CC EUDAMED551-BL-XL-CC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269528811 EUDAMED00840269528835 EUDAMED00840269528804 EUDAMED00840269528828 EUDAMED00840269528859 EUDAMED00840269528798 EUDAMED00840269528866 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
Elbow Brace for Tennis/Golf Elbow 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 (7)
- EUDAMED ceec3374-8c83-49b6-97b2-ad81299d609c 61 fields · synced Jul 30, 2026
- EUDAMED 4adcf592-3870-4c30-afee-59231f142c6c 61 fields · synced May 17, 2026
- EUDAMED c6887b1e-b0ae-404f-a708-4e6241f8468b 61 fields · synced May 17, 2026
- EUDAMED cfa3afdb-29ff-418a-94cd-504e0dccc2d0 61 fields · synced May 17, 2026
- EUDAMED 73e06406-7b24-47f7-880f-298766dcdc0e 61 fields · synced May 18, 2026
- EUDAMED a3000373-6742-460c-b440-af96cbfb1018 61 fields · synced May 18, 2026
- EUDAMED 1beae090-86d7-46cf-b72f-4a61c631e392 61 fields · synced May 19, 2026