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Eco-friendly Comfort Insoles
EUDAMEDClass I (EU MDR)
Ref 5015-N3-1Ref 5015-N5-1Ref 5015-N6-1Ref 5015-N7-1Ref 5015-N4-1
Identity
- Trade Name
- Eco-friendly Comfort Insoles EUDAMED
- Device Name
- FOOT ORTHOSES EUDAMED
- Model / Reference
- 5015-N3-1 EUDAMED5015-N5-1 EUDAMED5015-N6-1 EUDAMED5015-N7-1 EUDAMED5015-N4-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04711769156209 EUDAMED04711769156285 EUDAMED04711769156292 EUDAMED04711769156308 EUDAMED04711769156278 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
Eco-friendly Comfort 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 (5)
- EUDAMED de7e68fd-4bc0-4f8d-8f9c-82f4a9a0554c 61 fields · synced Aug 2, 2026
- EUDAMED 8a745e85-c353-4e27-a9c6-4c159bbb6c91 61 fields · synced May 17, 2026
- EUDAMED da634515-0cc2-457d-8d90-913b8158a84a 61 fields · synced May 17, 2026
- EUDAMED 8be7edd0-1061-4dd7-9e96-6530d1a49337 61 fields · synced May 17, 2026
- EUDAMED 6dfdffd6-4204-4ebf-95a5-9ca20bd728f7 61 fields · synced May 18, 2026