Identity
- Trade Name
- FOOTLOGICS COMFORT INSOLE M EUDAMED
- Device Name
- COMFORT INSOLE SIZE EUDAMED
- Model / Reference
- 1069.4CA M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08721161974352 EUDAMED
- Basic UDI-DI
- 8721161974FTLSCOMFORTV4 EUDAMED
- EMDN Code
- Y061203 ORTHOSES, FOOT (INCLUDING INSOLES AND INSERTS) EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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
Footlogics Comfort Insole M by Footlogics Europe B.V. — 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 | 8721161974FTLSCOMFORTV4 | Class I | Active |
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Manufacturer
- Manufacturer
- Footlogics Europe B.V.
- EUDAMED SRN
- NL-MF-000043504
Sources (1)
- EUDAMED f2a12a2b-58c0-47f7-a89b-6e1ca63f8c3d 61 fields · synced Jun 19, 2026