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Y061299
EUDAMEDClass I (EU MDR)
Ref Knee SupportRef COOLPRENE KNEE BRACE WITH ANGLE-ADJUSTABLE HINGES AND EXTRA PATELLAR TENDON SUPPORT
Identity
- Trade Name
- Y061299 EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- Knee Support EUDAMEDCOOLPRENE KNEE BRACE WITH ANGLE-ADJUSTABLE HINGES AND EXTRA PATELLAR TENDON SUPPORT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269514586 EUDAMED00840269511332 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
Y061299 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 (2)
- EUDAMED b0a49e4f-35af-4154-b3f6-ffc19849e9f4 61 fields · synced Jul 24, 2026
- EUDAMED f81d3a38-2421-4185-8ac3-8ae514b2d9fd 61 fields · synced May 18, 2026