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Open Patella Knee Support
EUDAMEDClass I (EU MDR)
Ref 758-TAN-FRef 788KM-BK-XLRef 788-TAN-XLRef 758KM-BK-FRef 788-BK-XLRef 788-BL-XLRef 758-BL-FRef 758-BK-F
Identity
- Trade Name
- Open Patella Knee Support EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 758-TAN-F EUDAMED788KM-BK-XL EUDAMED788-TAN-XL EUDAMED758KM-BK-F EUDAMED788-BK-XL EUDAMED788-BL-XL EUDAMED758-BL-F EUDAMED758-BK-F EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269520679 EUDAMED00840269502064 EUDAMED00840269524844 EUDAMED00840269502484 EUDAMED00840269522970 EUDAMED00840269524196 EUDAMED00840269520662 EUDAMED00840269520655 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
Open Patella 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 (8)
- EUDAMED 8c0bff24-1220-4d71-b7e5-a2f0314ddacc 61 fields · synced Aug 2, 2026
- EUDAMED c7decb54-0fe5-4657-a143-693c1af2cccb 61 fields · synced May 17, 2026
- EUDAMED 4e455ff6-6ea0-49aa-a9e0-4ced7481deab 61 fields · synced May 17, 2026
- EUDAMED ac4c995c-3390-421d-800b-7d0fb20f5875 61 fields · synced May 18, 2026
- EUDAMED 83f475a0-ebdf-4b0c-89e1-77c989855b26 61 fields · synced May 18, 2026
- EUDAMED 4e5773f4-407f-4515-aa4c-1ff79f76ade0 61 fields · synced May 18, 2026
- EUDAMED 086a8cf0-b170-4cde-898b-cf7aee9dc3a9 61 fields · synced May 18, 2026
- EUDAMED 5e2e8022-fd04-470a-b94e-e48e4a7ee00a 61 fields · synced May 19, 2026