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Elbow Sleeve
EUDAMEDClass I (EU MDR)
Ref HME200-BK-LRef HME200-BK-SRef HME200-BK-M
Identity
- Trade Name
- ELBOW SLEEVE EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- HME200-BK-L EUDAMEDHME200-BK-S EUDAMEDHME200-BK-M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269528408 EUDAMED00840269528385 EUDAMED00840269528392 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 Sleeve 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 (3)
- EUDAMED fa13d56e-777d-461c-8728-e3fd3f3b0a31 61 fields · synced Jul 28, 2026
- EUDAMED 9f04be95-3abe-4fe7-bdda-be6bae760225 61 fields · synced May 18, 2026
- EUDAMED 0a9096ed-7c9e-4c3b-b6c2-6f4b25e493e9 61 fields · synced May 19, 2026