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Coolprene Knee Sleeve With Oval Pad
EUDAMEDClass I (EU MDR)
Ref 707CN-BL-XLRef 707CN-BL-LRef 707CN-BK-MRef 707CN-BK-LRef 707CN-BK-XL
Identity
- Trade Name
- COOLPRENE KNEE SLEEVE WITH OVAL PAD EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 707CN-BL-XL EUDAMED707CN-BL-L EUDAMED707CN-BK-M EUDAMED707CN-BK-L EUDAMED707CN-BK-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269526183 EUDAMED00840269526176 EUDAMED00840269526121 EUDAMED00840269526138 EUDAMED00840269526145 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 Knee Sleeve With Oval Pad 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 (5)
- EUDAMED 95ab70a1-e57b-4974-8b81-e056789ec394 61 fields · synced Jul 25, 2026
- EUDAMED b0884087-0b18-4a31-900e-18b2ba8c2263 61 fields · synced May 17, 2026
- EUDAMED 60a0e6f1-f602-45a9-a3d1-8e6e279de6be 61 fields · synced May 17, 2026
- EUDAMED e6397a79-b5f7-4393-8efb-18bdc7346ef8 61 fields · synced May 17, 2026
- EUDAMED ecffdeee-ba4d-4ac5-8b98-65566c9465e1 61 fields · synced May 18, 2026