Identity
- Trade Name
- FOOTLOGICS SENSI INSOLE XL EUDAMED
- Device Name
- FOOTLOGICS SENSI INSOLE EUDAMED
- Model / Reference
- 1053APS XL EUDAMED1053APS EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08721161974567 EUDAMED08721161974550 EUDAMED
- Basic UDI-DI
- 8721161974FTLSSENSI6A 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 Sensi Insole Xl 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 | 8721161974FTLSSENSI6A | Class I | Active |
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Manufacturer
- Manufacturer
- Footlogics Europe B.V.
- EUDAMED SRN
- NL-MF-000043504
Sources (2)
- EUDAMED 37810859-41c0-4e9a-9023-7b2c6db5c85b 61 fields · synced Oct 6, 2026
- EUDAMED f4ab30eb-314d-410a-ace2-be1e923ced79 61 fields · synced May 16, 2026