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Antibacterial Dual Density Foam insoles
EUDAMEDClass I (EU MDR)
Ref 5015DM-N2-1Ref 5015DM-N4-1
Identity
- Trade Name
- Antibacterial Dual Density Foam insoles EUDAMED
- Device Name
- FOOT ORTHOSES EUDAMED
- Model / Reference
- 5015DM-N2-1 EUDAMED5015DM-N4-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711769143490 EUDAMED04711769143513 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
Antibacterial Dual Density Foam insoles 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 (2)
- EUDAMED 762ab50c-0df7-4927-97f5-9e6e01c901c0 61 fields · synced Jul 14, 2026
- EUDAMED 76c51782-5c35-46e8-8b82-14b73ef355a5 61 fields · synced May 19, 2026