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COOLPRENE Knee Support
EUDAMEDClass I (EU MDR)
Ref 756CN-TAN-FRef HMK101-BK-FRef 788CN-TAN-XLRef 756CN-BK-FRef 788CN-BL-FRef 788CN-BL-XLRef 788CN-BK-XL
Identity
- Trade Name
- COOLPRENE Knee Support EUDAMEDCOOLPRENE Knee Support with Patella Support Ring EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 756CN-TAN-F EUDAMEDHMK101-BK-F EUDAMED788CN-TAN-XL EUDAMED756CN-BK-F EUDAMED788CN-BL-F EUDAMED788CN-BL-XL EUDAMED788CN-BK-XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269503887 EUDAMED00840269528514 EUDAMED00840269503566 EUDAMED00840269503726 EUDAMED00840269501395 EUDAMED00840269501401 EUDAMED00840269507335 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 Support 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 (7)
- EUDAMED ebc00b29-91ba-4d22-9893-51dc57b11823 61 fields · synced Aug 5, 2026
- EUDAMED 6107f6a5-c64c-434f-a591-a8336742d26c 61 fields · synced May 16, 2026
- EUDAMED 95a767bb-c39c-48c6-a9ad-e5ee31dd921f 61 fields · synced May 17, 2026
- EUDAMED 0ce4dbcb-20c8-4c78-8614-34ba4482eb4f 61 fields · synced May 17, 2026
- EUDAMED 47e06c07-9367-4282-8b3e-c56fa8c3b065 61 fields · synced May 18, 2026
- EUDAMED cd6ac91e-239c-44c7-a7c1-f510a518ab55 61 fields · synced May 18, 2026
- EUDAMED 568e65bd-14aa-47e0-b41d-0aeb61ee3d3e 61 fields · synced May 19, 2026