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Full Length Silicone Insole Without Met Pad - Size 36 (Pair)
EUDAMEDClass I (EU MDR)
Ref SI-FL-36Model SI-FL
by Chaneco Ltd
Identity
- Trade Name
- Full Length Silicone Insole Without Met Pad - Size 36 (Pair) EUDAMED
- Device Name
- Full Length Silicone Insole EUDAMED
- Model / Reference
- SI-FL EUDAMEDSI-FL-36 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05056157603217 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
Category: Orthotic insole, prefabricated, non-antimicrobial
Full Length Silicone Insole Without Met Pad - Size 36 (Pair) by Chaneco Ltd — 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 | 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 5749156e-51e5-4be9-971b-f134aeec5fe3 61 fields · synced Jul 9, 2026