Identity
- Trade Name
- Gel Cushion EUDAMED
- Device Name
- FOOT ORTHOSES EUDAMED
- Model / Reference
- 6705-M-1 EUDAMED6705-S-1 EUDAMED6705-L-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711769147719 EUDAMED04711769147702 EUDAMED04711769147726 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
Gel Cushion by OPPO Medical Corp. — 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 | 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 (3)
- EUDAMED 1bebdcd7-f5d0-4d6e-a60c-0c2c5a798d7f 61 fields · synced Jul 19, 2026
- EUDAMED 27884533-9b46-474d-a1f5-b3acdeadad1b 61 fields · synced May 18, 2026
- EUDAMED ae6ae1c1-fefb-4065-ae3b-93b93737b80d 61 fields · synced May 19, 2026