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Shin and Calf Sleeve
EUDAMEDClass I (EU MDR)
Ref 718-BK-XSRef 718-BL-XSRef 718-TAN-MRef 718-TAN-LRef 718-BK-XLRef 718-TAN-SRef 718-BK-SRef 718-BL-SRef 718-BK-L
Identity
- Trade Name
- Shin and Calf Sleeve EUDAMED
- Device Name
- LOWER EXTREMITY ORTHOSES EUDAMED
- Model / Reference
- 718-BK-XS EUDAMED718-BL-XS EUDAMED718-TAN-M EUDAMED718-TAN-L EUDAMED718-BK-XL EUDAMED718-TAN-S EUDAMED718-BK-S EUDAMED718-BL-S EUDAMED718-BK-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269517686 EUDAMED00840269517693 EUDAMED00840269517761 EUDAMED00840269517792 EUDAMED00840269517808 EUDAMED00840269517730 EUDAMED00840269517716 EUDAMED00840269517723 EUDAMED00840269517778 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
Shin and Calf 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 (9)
- EUDAMED f19df487-7ba5-4574-9138-30954519e3f1 61 fields · synced Jul 29, 2026
- EUDAMED 0a63ac3c-8b14-4b27-bb3a-2e19baf7c2b6 61 fields · synced May 17, 2026
- EUDAMED 2930c3d4-7128-441e-98e7-ac17c2216a4a 61 fields · synced May 17, 2026
- EUDAMED 0eb160f1-d6e8-444f-afc7-86c9e94b27a7 61 fields · synced May 17, 2026
- EUDAMED 3e47083d-3784-4dfe-9bd0-5925543ce765 61 fields · synced May 18, 2026
- EUDAMED 89518fb2-a0ae-485c-94da-85364ef69924 61 fields · synced May 18, 2026
- EUDAMED 35800501-1910-4709-89aa-fec1729e745b 61 fields · synced May 18, 2026
- EUDAMED eb28b04d-cee6-47e9-b1d9-b5b85cc820a5 61 fields · synced May 19, 2026
- EUDAMED e496f054-c9f6-4770-a78b-5c83c3e51e60 61 fields · synced May 19, 2026