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Elbow Guard
EUDAMEDClass I (EU MDR)
Ref 522CA-BK-MRef 522CA-BK-LRef 522CA-BK-SRef 522CA-BK-XL
Identity
- Trade Name
- Elbow Guard EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 522CA-BK-M EUDAMED522CA-BK-L EUDAMED522CA-BK-S EUDAMED522CA-BK-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269504181 EUDAMED00840269504358 EUDAMED00840269503894 EUDAMED00840269504525 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 Guard 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 236278bf-928e-4ddd-9d0c-f27a2bfb8b18 61 fields · synced Aug 1, 2026
- EUDAMED 19d41bb7-a34a-41ed-8bf6-33ad89cc4633 61 fields · synced May 17, 2026
- EUDAMED d8a41aff-f3e3-49ad-b00b-b332c23f5acb 61 fields · synced May 18, 2026
- EUDAMED 1705c41c-ea8b-43e8-89ae-3fffdedec8e7 61 fields · synced May 19, 2026