Identity
- Trade Name
- FeetMe Monitor EUDAMEDFeetMe Monitor FTM-DK FDA UDI
- Generic Name
- Pressure monitoring insole FDA UDI
- Device Name
- FeetMe Monitor EUDAMEDMedical device corresponding to a pair of connected insoles model FTM-DK, version PVT1 FDA UDI
- Model / Reference
- FTM-DK EUDAMEDPVT1 FDA UDI
- Description
- Medical device corresponding to a pair of connected insoles model FTM-DK, version PVT1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 03760349820000 EUDAMEDFDA UDI
- Basic UDI-DI
- B-03760349820000 EUDAMED
- FDA Product Code
- JFC FDA UDI
- EMDN Code
- Z12062602 SENSOR-BASED INSOLES EUDAMED
- GMDN Term
- Pressure monitoring insole FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 890.1600 FDA UDI
- Market of Registration
- France EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
FeetMe Monitor by Feetme — Class I — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union No Longer Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-03760349820000 | Class I | No Longer Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Feetme
- EUDAMED SRN
- FR-MF-000007674
Sources (2)
- EUDAMED 1f3fd47d-bf52-4549-8d5b-68620b305b26 61 fields · synced Jun 8, 2026
- FDA UDI 128e6953-ec77-4c83-a589-9d668d091905 35 fields · synced May 30, 2026