Identity
- Trade Name
- Halluxcare Straighteners EUDAMED
- Device Name
- FOOT ORTHOSES EUDAMED
- Model / Reference
- 327-M EUDAMED327-S EUDAMED327-L EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00840269509070 EUDAMED00840269509063 EUDAMED00840269509087 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 Straighteners 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 3d112cde-dc24-48f9-adcb-1e531e393bf9 61 fields · synced Aug 1, 2026
- EUDAMED 29eff5b2-80d0-4a33-9db1-5bf0bdec2cf3 61 fields · synced May 18, 2026
- EUDAMED e7114397-3702-44ff-a598-0c2a453cc597 61 fields · synced May 19, 2026