Identity
- Trade Name
- FOOTLOGICS COMFORT INSOLE XL EUDAMED
- Device Name
- COMFORT INSOLE SIZE EUDAMED
- Model / Reference
- 1069.4CA XL EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08721161974543 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
Category: Orthotic insole, prefabricated, non-antimicrobial
Footlogics Comfort Insole Xl by Footlogics Europe B.V. — 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 | 8721161974FTLSCOMFORTV4 | Class I | Active |
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Manufacturer
- Manufacturer
- Footlogics Europe B.V.
- EUDAMED SRN
- NL-MF-000043504
Sources (1)
- EUDAMED 1a7a755e-62e4-4c45-8007-052658d1252d 61 fields · synced Oct 7, 2026