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Silicone Insole
EUDAMEDClass I (EU MDR)
Ref Silicon Insole (M)Ref Silicon Insole (S)Ref Silicon Insole (L)
Identity
- Device Name
- Silicone Insole EUDAMED
- Model / Reference
- Silicon Insole (M) EUDAMEDSilicon Insole (S) EUDAMEDSilicon Insole (L) EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08906176121292 EUDAMED08906176121285 EUDAMED08906176121308 EUDAMED
- Basic UDI-DI
- 890617612MS03HY EUDAMED
- Direct Marketing DI
- 08906176121292 EUDAMED08906176121285 EUDAMED08906176121308 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
Silicone Insole by Medequip Healthcare Solutions Pvt Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 890617612MS03HY | Class I | Active |
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Manufacturer
- Manufacturer
- Medequip Healthcare Solutions Pvt Ltd
- EUDAMED SRN
- IN-MF-000039598
- Authorised Representative
- AF Pharma Service Europe SL ES-AR-000018076
Sources (3)
- EUDAMED fa36b78c-3c7c-4c8f-ae9f-4e8949785eaa 61 fields · synced Oct 6, 2026
- EUDAMED 2ee4e489-be85-4039-a0a8-fc7574d72b73 61 fields · synced May 17, 2026
- EUDAMED eabc5546-e923-4d63-92ec-190faf4446a3 61 fields · synced May 18, 2026