Identity
- Trade Name
- FOOTLOGICS COMFORT PLUS INSOLE XS EUDAMED
- Device Name
- COMFORT PLUS INSOLE EUDAMED
- Model / Reference
- 1069.4SVP XS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08721161974369 EUDAMED
- Basic UDI-DI
- 8721161974FTLSCMFRTPLUSGQ 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 Plus Insole Xs 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 | 8721161974FTLSCMFRTPLUSGQ | Class I | Active |
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Manufacturer
- Manufacturer
- Footlogics Europe B.V.
- EUDAMED SRN
- NL-MF-000043504
Sources (1)
- EUDAMED a5693680-43ba-432c-a971-d3160986239f 61 fields · synced Oct 5, 2026