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Knee Sleeve
EUDAMEDClass I (EU MDR)
Ref 647R1-YW-LRef 647R1-BL-SRef 647R1-WT-XLRef 647R1-BK-XLRef 647R1-YW-SRef 647R1-BL-MRef HMK200-BK-XLRef 647R1-DB-MRef 647R1-GY-MRef 647R1-DB-XLRef 647R1-BR-XLRef 647R1-YW-MRef HMK200-BK-MRef 647R1-BR-LRef 647R1-BR-SRef 647R1-BK-LRef 647R1-WT-L
Identity
- Trade Name
- Knee Sleeve EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 647R1-YW-L EUDAMED647R1-BL-S EUDAMED647R1-WT-XL EUDAMED647R1-BK-XL EUDAMED647R1-YW-S EUDAMED647R1-BL-M EUDAMEDHMK200-BK-XL EUDAMED647R1-DB-M EUDAMED647R1-GY-M EUDAMED647R1-DB-XL EUDAMED647R1-BR-XL EUDAMED647R1-YW-M EUDAMEDHMK200-BK-M EUDAMED647R1-BR-L EUDAMED647R1-BR-S EUDAMED647R1-BK-L EUDAMED647R1-WT-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269506703 EUDAMED00840269505676 EUDAMED00840269505744 EUDAMED00840269505669 EUDAMED00840269506628 EUDAMED00840269505683 EUDAMED00840269528569 EUDAMED00840269505935 EUDAMED00840269505973 EUDAMED00840269505959 EUDAMED00840269505850 EUDAMED00840269506666 EUDAMED00840269528545 EUDAMED00840269505799 EUDAMED00840269505751 EUDAMED00840269505652 EUDAMED00840269505737 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
Knee Sleeve 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 (17)
- EUDAMED 5c4d1318-008c-4e5b-bad9-c70605822992 61 fields · synced Sep 18, 2026
- EUDAMED abeb44ca-2011-4289-86ad-4c68d241eda7 61 fields · synced May 16, 2026
- EUDAMED ca3a2e9e-db1f-4a3a-a288-21778473c008 61 fields · synced May 16, 2026
- EUDAMED 65ac6aa1-2595-475c-9d18-aa1851b5df56 61 fields · synced May 16, 2026
- EUDAMED e753f6bb-65b5-46c2-8d29-8889be834361 61 fields · synced May 16, 2026
- EUDAMED b334f279-8bfb-4f7e-a944-70bc4357f0fe 61 fields · synced May 17, 2026
- EUDAMED eb9e721b-bfda-4b14-99c9-8886144ba1f6 61 fields · synced May 17, 2026
- EUDAMED 753ea7ce-3a1e-4061-a9a5-e3519f5e856e 61 fields · synced May 17, 2026
- EUDAMED 9288fa5e-fb38-4a35-96c3-e8d661a03536 61 fields · synced May 17, 2026
- EUDAMED ccb05cad-0c5f-4a02-85a4-363e166386d4 61 fields · synced May 17, 2026
- EUDAMED 51606c40-b2ca-4920-bcd6-59057883ac30 61 fields · synced May 17, 2026
- EUDAMED 706c1589-5bce-4a79-bec0-f0d366953b2d 61 fields · synced May 18, 2026
- EUDAMED abe4580b-525b-43d5-924f-5a24ae8e9b5c 61 fields · synced May 18, 2026
- EUDAMED eea30ecf-cdaf-4397-ba7d-b8d8b8fa3995 61 fields · synced May 18, 2026
- EUDAMED 02562b08-01bb-485c-ae03-05f70b13e73e 61 fields · synced May 18, 2026
- EUDAMED 00340748-915a-4316-a021-ba144eed7c7a 61 fields · synced May 18, 2026
- EUDAMED d59d5f04-5e72-48db-a320-3d05a999d092 61 fields · synced May 18, 2026