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Performance Arm Sleeve
EUDAMEDClass I (EU MDR)
Ref SL51-RD-MRef SL51-BL-MRef SL51-WT-SRef SL51-PK-SRef SL51-PK-LRef SL51-BL-LRef SL51-WT-LRef SL51-BL-SRef SL51-BK-MRef SL51-RD-L
Identity
- Trade Name
- Performance Arm Sleeve EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- SL51-RD-M EUDAMEDSL51-BL-M EUDAMEDSL51-WT-S EUDAMEDSL51-PK-S EUDAMEDSL51-PK-L EUDAMEDSL51-BL-L EUDAMEDSL51-WT-L EUDAMEDSL51-BL-S EUDAMEDSL51-BK-M EUDAMEDSL51-RD-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269502668 EUDAMED00840269502637 EUDAMED00840269502590 EUDAMED00840269502699 EUDAMED00840269502712 EUDAMED00840269502644 EUDAMED00840269502613 EUDAMED00840269502620 EUDAMED00840269502576 EUDAMED00840269502675 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
Performance Arm 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 (10)
- EUDAMED 1254523a-0a1a-41b3-b720-c8fe80941b75 61 fields · synced Aug 3, 2026
- EUDAMED 18fac634-d61a-4c10-9252-051b326650a8 61 fields · synced May 11, 2026
- EUDAMED 1fbec403-142d-47e4-8018-d6b21bad36a5 61 fields · synced May 16, 2026
- EUDAMED edd895ea-ade9-48fc-a19b-591364c68fd9 61 fields · synced May 17, 2026
- EUDAMED 153c9381-50d1-4e17-8add-0f3b8df2eb7c 61 fields · synced May 17, 2026
- EUDAMED a89dd26d-3858-4601-8d83-10d36ab89c3f 61 fields · synced May 17, 2026
- EUDAMED e771880c-1b8b-41b9-9766-992688008ff4 61 fields · synced May 17, 2026
- EUDAMED a1e8f17d-af68-485e-88be-875292552f42 61 fields · synced May 17, 2026
- EUDAMED f890051d-e17f-4ca6-8a11-d44429a222c7 61 fields · synced May 17, 2026
- EUDAMED 58b11df8-4599-4971-930d-b3c65dccb184 61 fields · synced May 18, 2026