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X-Knee Support
EUDAMEDClass I (EU MDR)
Ref 639-TAN-LRef 639-TAN-XLRef 788CAR1-BK-FRef 758CAR1-BK-F-1Ref 758CAR1-BK-FRef 788CN-BK-F
Identity
- Trade Name
- X-Knee Support EUDAMEDCOOLPRENE X Knee Support with Patella Support Ring EUDAMEDCOOLPRENE X Knee Support with Patella Support Ring (Added Length) EUDAMEDCOOLPRENE Knee Support with Patella Support Ring EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 639-TAN-L EUDAMED639-TAN-XL EUDAMED788CAR1-BK-F EUDAMED758CAR1-BK-F-1 EUDAMED758CAR1-BK-F EUDAMED788CN-BK-F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269513404 EUDAMED00840269513428 EUDAMED00840269506987 EUDAMED04719890078865 EUDAMED00840269504723 EUDAMED00840269506826 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
X-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 (6)
- EUDAMED 5d2be77a-1fe7-4302-bd4c-ec84962a344d 61 fields · synced Jul 27, 2026
- EUDAMED 2956d1be-7129-4d7e-aa44-c95ee32ffd6b 61 fields · synced May 18, 2026
- EUDAMED ca09bf21-6039-4f70-a6d8-96f7791d4178 61 fields · synced May 18, 2026
- EUDAMED b4384912-90d0-4c21-a644-f6e9802430ad 61 fields · synced May 18, 2026
- EUDAMED a3f80202-b2db-4840-9b98-094bcb3765e4 61 fields · synced May 18, 2026
- EUDAMED 9d20a0a9-c4b2-43db-a63e-418f278b9dc8 61 fields · synced May 19, 2026