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Hallux Valgus Protector
EUDAMEDClass I (EU MDR)
Ref 6443-L/XL-1Ref 6443-S/M-1Ref 6440-L/XL-1Ref 6440-S/M-1
Identity
- Trade Name
- Hallux Valgus Protector EUDAMED
- Device Name
- FOOT ORTHOSES EUDAMED
- Model / Reference
- 6443-L/XL-1 EUDAMED6443-S/M-1 EUDAMED6440-L/XL-1 EUDAMED6440-S/M-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711769145739 EUDAMED04711769145722 EUDAMED04719863696478 EUDAMED04719863696461 EUDAMED
- Basic UDI-DI
- 471986369CL107DR EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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
Hallux Valgus Protector by OPPO Medical Corp. — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 | 471986369CL107DR | Class I | Active |
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Manufacturer
- Manufacturer
- OPPO Medical Corp.
- EUDAMED SRN
- TW-MF-000005201
- Authorised Representative
- Medical Technology Promedt Consulting GmbH DE-AR-000000085
Sources (4)
- EUDAMED cde9301f-ea6b-4187-ae30-1ce44c9ba950 61 fields · synced Oct 6, 2026
- EUDAMED 3b038116-b45b-4610-b5b6-45f34de7ad3d 61 fields · synced May 17, 2026
- EUDAMED 27618061-c826-4092-8ead-4eb6ea98552d 61 fields · synced May 17, 2026
- EUDAMED e6cdb36f-7026-4a86-ba2a-b615a934ee5d 61 fields · synced May 18, 2026