Identity
- Trade Name
- Halluxcare Bunion Sleeve EUDAMED
- Device Name
- FOOT ORTHOSES EUDAMED
- Model / Reference
- 350-M EUDAMED350-L EUDAMED350-S EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269509469 EUDAMED00840269509476 EUDAMED00840269509452 EUDAMED
- Basic UDI-DI
- 08402695CL1068N EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) 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
Category: Orthotic insole, prefabricated, non-antimicrobial
Halluxcare Bunion Sleeve by La Pointique Int´l Ltd. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Also classified as Orthotic insole, prefabricated, non-antimicrobial.
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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 | 08402695CL1068N | 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 (3)
- EUDAMED 5c760c53-3dc1-45a2-9807-3bfe0be31a43 61 fields · synced Jul 21, 2026
- EUDAMED 0571aaf0-e7f7-4a76-88af-abfc2d63a35f 61 fields · synced May 17, 2026
- EUDAMED fe4d0ba8-809c-44f0-b8cf-83118b8545e6 61 fields · synced May 18, 2026