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Full Length Silicone Insole Without Met Pad - Size 46 (Pair)
EUDAMEDClass I (EU MDR)
Ref SI-FL-46Model SI-FL
by Chaneco Ltd
Identity
- Trade Name
- Full Length Silicone Insole Without Met Pad - Size 46 (Pair) EUDAMED
- Device Name
- Full Length Silicone Insole EUDAMED
- Model / Reference
- SI-FL EUDAMEDSI-FL-46 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056157603262 EUDAMED
- Basic UDI-DI
- 5056157634SilInsoleLW 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
Full Length Silicone Insole Without Met Pad - Size 46 (Pair) by Chaneco 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 | 5056157634SilInsoleLW | Class I | Active |
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Manufacturer
- Manufacturer
- Chaneco Ltd
- EUDAMED SRN
- UK-MF-000043937
- Authorised Representative
- UKALIA Limited XI-AR-000024526
Sources (1)
- EUDAMED 3df296fc-a742-4658-8bbb-79f86ba5b3ec 61 fields · synced Jun 19, 2026