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Arm Compression Sleeve
EUDAMEDClass I (EU MDR)
Ref 251Z-OR-MRef 251Z-OB-MRef 251Z-OB-XXLRef 251Z-OW-XXLRef 251Z-BK-XXLRef 251Z-OL-XXXLRef 251Z-OB-XXXLRef 251Z-WT-SRef 251Z-OR-XLRef 251Z-WT-MRef 251Z-RD-SRef 251Z-RD-XXLRef 251Z-BL-XXLRef 251Z-OW-XXXLRef 251Z-BL-XXXLRef 251Z-BK-XXXLRef 251Z-BK-MRef 251Z-OW-LRef 251Z-WT-XXXLRef 251Z-BL-MRef 251Z-OW-XLRef 251Z-WT-XXLRef 251Z-OR-XXLRef 251Z-OB-XLRef 251Z-WT-XLRef 251Z-BK-L
Identity
- Trade Name
- Arm Compression Sleeve EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 251Z-OR-M EUDAMED251Z-OB-M EUDAMED251Z-OB-XXL EUDAMED251Z-OW-XXL EUDAMED251Z-BK-XXL EUDAMED251Z-OL-XXXL EUDAMED251Z-OB-XXXL EUDAMED251Z-WT-S EUDAMED251Z-OR-XL EUDAMED251Z-WT-M EUDAMED251Z-RD-S EUDAMED251Z-RD-XXL EUDAMED251Z-BL-XXL EUDAMED251Z-OW-XXXL EUDAMED251Z-BL-XXXL EUDAMED251Z-BK-XXXL EUDAMED251Z-BK-M EUDAMED251Z-OW-L EUDAMED251Z-WT-XXXL EUDAMED251Z-BL-M EUDAMED251Z-OW-XL EUDAMED251Z-WT-XXL EUDAMED251Z-OR-XXL EUDAMED251Z-OB-XL EUDAMED251Z-WT-XL EUDAMED251Z-BK-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269500312 EUDAMED00840269500299 EUDAMED00840269500411 EUDAMED00840269500442 EUDAMED00840269503863 EUDAMED00840269500466 EUDAMED00840269500459 EUDAMED00840269508882 EUDAMED00840269500398 EUDAMED00840269508899 EUDAMED00840269506062 EUDAMED00840269506109 EUDAMED00840269505027 EUDAMED00840269500480 EUDAMED00840269505034 EUDAMED00840269503870 EUDAMED00840269503832 EUDAMED00840269500367 EUDAMED00840269508936 EUDAMED00840269504990 EUDAMED00840269500404 EUDAMED00840269508929 EUDAMED00840269500435 EUDAMED00840269500374 EUDAMED00840269508912 EUDAMED00840269503849 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
Arm Compression 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 (26)
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