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Silicone Elastmax Insoles
EUDAMEDClass I (EU MDR)
Ref 5407-N2-1Ref 5401-N5-1Ref 5401-N1-1Ref 5407-N4-1Ref 5407-N5-1Ref 5407-N3-1
Identity
- Trade Name
- Silicone Elastmax Insoles EUDAMED
- Device Name
- FOOT ORTHOSES EUDAMED
- Model / Reference
- 5407-N2-1 EUDAMED5401-N5-1 EUDAMED5401-N1-1 EUDAMED5407-N4-1 EUDAMED5407-N5-1 EUDAMED5407-N3-1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04719863695952 EUDAMED04719863695006 EUDAMED04719863694665 EUDAMED04719863695976 EUDAMED04719863695983 EUDAMED04719863695969 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
Silicone Elastmax Insoles 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 (6)
- EUDAMED 2df2d46c-fa35-49a4-b5dd-e2f93526dd92 61 fields · synced Jul 26, 2026
- EUDAMED c07c166a-a763-4ac8-bf12-dbb47c35769a 61 fields · synced May 16, 2026
- EUDAMED b54fb2c2-377c-4534-b6a8-1b2df6536a2b 61 fields · synced May 17, 2026
- EUDAMED 5a56a458-e7cd-411a-86bb-3c8cc7e4683d 61 fields · synced May 17, 2026
- EUDAMED f7a16c58-9e26-4bff-b7b3-b35eaa659ae5 61 fields · synced May 18, 2026
- EUDAMED 4c461bce-d619-4ea4-8b34-684c28bde7cd 61 fields · synced May 18, 2026