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COOLPRENE X Knee Sleeve with Open Patella
EUDAMEDClass I (EU MDR)
Ref 708CAR1-BK-MRef 708CAR1-BK-SRef 708CAR1-BK-XL
Identity
- Trade Name
- COOLPRENE X Knee Sleeve with Open Patella EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 708CAR1-BK-M EUDAMED708CAR1-BK-S EUDAMED708CAR1-BK-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269505515 EUDAMED00840269505508 EUDAMED00840269505539 EUDAMED
- Basic UDI-DI
- 08402695CL1028E EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - 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 Knee Sleeve with Open Patella 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 | 08402695CL1028E | 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 e3bbf0af-9102-42d3-ad41-df8cf968d931 61 fields · synced Jul 31, 2026
- EUDAMED 5c6b4aa0-da14-4b83-8ea2-0548a11aa879 61 fields · synced May 17, 2026
- EUDAMED af9d1a82-128f-43bc-bd26-ca1cb0ad7b37 61 fields · synced May 18, 2026