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COOLPRENE Knee Support with Patella Support Ring and Extra Side Supports
EUDAMEDClass I (EU MDR)
Ref 533CN-BK-FRef 733CN-BK-XLRef 537CN-BK-F-1Ref 537CN-BK-XLRef 533CN-BK-XL-1Ref 733CN-BK-F-1Ref 733CN-BK-XL-1Ref 533CN-BK-XLRef 537CN-BK-XL-1
Identity
- Trade Name
- COOLPRENE Knee Support with Patella Support Ring and Extra Side Supports EUDAMEDCOOLPRENE Knee Support with Patella Support Ring and Extra Side and Front Supports (Added Length) EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 533CN-BK-F EUDAMED733CN-BK-XL EUDAMED537CN-BK-F-1 EUDAMED537CN-BK-XL EUDAMED533CN-BK-XL-1 EUDAMED733CN-BK-F-1 EUDAMED733CN-BK-XL-1 EUDAMED533CN-BK-XL EUDAMED537CN-BK-XL-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269529191 EUDAMED00840269507342 EUDAMED04719884893498 EUDAMED00840269529221 EUDAMED04719884893467 EUDAMED04719890072184 EUDAMED04719890072191 EUDAMED00840269529207 EUDAMED04719884893528 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 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 (9)
- EUDAMED 169e45a1-21e2-4952-af45-411b9ee47745 61 fields · synced Aug 4, 2026
- EUDAMED 9032c443-e279-45ea-b074-8fbb24ed3385 61 fields · synced May 16, 2026
- EUDAMED 6fb03658-418e-40de-8918-b8575e44ce5d 61 fields · synced May 16, 2026
- EUDAMED d69e25bb-95ee-45fa-bd63-55d23318af84 61 fields · synced May 16, 2026
- EUDAMED 9856e7db-a0c7-4e81-81d2-5ba89011aab8 61 fields · synced May 17, 2026
- EUDAMED 67096aa6-f01e-4aba-967a-8eb2ae7fcf4a 61 fields · synced May 18, 2026
- EUDAMED 67cfc333-8ce0-4fe5-8459-9cfe9db29a7d 61 fields · synced May 18, 2026
- EUDAMED f76f0496-9a73-4971-9930-ebb7ae8bb5c5 61 fields · synced May 18, 2026
- EUDAMED 3aa55494-4297-4d48-aa83-8239498de3a3 61 fields · synced May 19, 2026