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COOLPRENE X Shoulder Support
EUDAMEDClass I (EU MDR)
Ref 538CAR1-BK-MRef 538CAR1-BK-LRef 538CAR1-BK-SRef 538CAR1-BK-XL
Identity
- Trade Name
- COOLPRENE X Shoulder Support EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 538CAR1-BK-M EUDAMED538CAR1-BK-L EUDAMED538CAR1-BK-S EUDAMED538CAR1-BK-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269504860 EUDAMED00840269504877 EUDAMED00840269504853 EUDAMED00840269505416 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
COOLPRENE X Shoulder Support 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 80b2e330-d66e-4adb-8b11-98208adfc8a3 61 fields · synced Jul 21, 2026
- EUDAMED 7699e5d9-6618-4422-bfcc-ca1a1e2184ce 61 fields · synced May 17, 2026
- EUDAMED ceff972c-b31c-4617-ba9a-de47e141e736 61 fields · synced May 18, 2026
- EUDAMED e69a36cd-f573-49e8-8e26-c84a48e96a3f 61 fields · synced May 18, 2026