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COOLPRENE X Elbow Sleeve
EUDAMEDClass I (EU MDR)
Ref FT55CA-BK-SRef FT55CA-BK-MRef FT55CA-BK-XL
Identity
- Trade Name
- COOLPRENE X Elbow Sleeve EUDAMED
- Device Name
- UPPER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- FT55CA-BK-S EUDAMEDFT55CA-BK-M EUDAMEDFT55CA-BK-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269507533 EUDAMED00840269506956 EUDAMED00840269507557 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 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 7265fc3a-a37a-4e59-9d7c-a0a420071885 61 fields · synced Jul 30, 2026
- EUDAMED c60b1e6e-4e91-45d9-8230-df69ff90ef2c 61 fields · synced May 17, 2026
- EUDAMED be26d8f7-f6f8-4ca7-a30c-6a2a1d8f22bc 61 fields · synced May 17, 2026