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COOLPRENE X Knee Support with Patella Support Ring and Extra Side Supports
EUDAMEDClass I (EU MDR)
Ref 733CAR1-BK-FRef 533CAR1-BK-F-1Ref 733CAR1-BK-F-1Ref 533CAR1-BK-F
Identity
- Trade Name
- COOLPRENE X Knee Support with Patella Support Ring and Extra Side Supports EUDAMEDCOOLPRENE X Knee Support with Patella Support Ring and Extra Side and Front Supports EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 733CAR1-BK-F EUDAMED533CAR1-BK-F-1 EUDAMED733CAR1-BK-F-1 EUDAMED533CAR1-BK-F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269506970 EUDAMED04719890077608 EUDAMED04719890072160 EUDAMED00840269503757 EUDAMED
- Basic UDI-DI
- 08402695CL1028E EUDAMED471988489CL102GJ EUDAMED
- EMDN Code
- Y061299 LOWER EXTREMITY ORTHOSES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMEDMalta 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 Support with Patella Support Ring and Extra Side Supports by La Pointique Int´l Ltd. — Class I — MDR — listed in EUDAMED
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 (4)
- EUDAMED c644cae1-d8b5-4b1f-8160-a1fc0ff3d936 61 fields · synced Jul 30, 2026
- EUDAMED f888730e-5f09-4051-ad2e-67fed7cf737a 61 fields · synced May 17, 2026
- EUDAMED b978ce0b-9595-4246-8512-cdae8074d0c3 61 fields · synced May 18, 2026
- EUDAMED 1e3e8e64-55e4-462d-bd89-da10ddf3226a 61 fields · synced May 19, 2026