Identity
- Trade Name
- OvuSense FDA UDI
- Generic Name
- Thermometric fertility analyser FDA UDI
- Device Name
- M400 OvuFirst Starter Pack - M426 OvuFirst Skin Worn Sensor and M032 OvuSense App FDA UDI
- Model / Reference
- M400 FDA UDI
- Description
- M400 OvuFirst Starter Pack - M426 OvuFirst Skin Worn Sensor and M032 OvuSense App FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060508530121 FDA UDI
- FDA Product Code
- LHD FDA UDI
- GMDN Term
- Thermometric fertility analyser FDA UDI
Classification
- Device Class
- U FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Thermometric fertility analyser
OvuSense by Vio Healthtech Limited — Class U — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Thermometric fertility analyser.
- OVY by Beurer — BEURER NORTH AMERICA, L.P. · U
- Beurer — BEURER NORTH AMERICA, L.P. · U
- raiing iFertracker — Raiing Medical Company · U
- femSense Ovulation Tracker — SteadySense GmbH · U
- OvuSense — VIO HEALTHTECH LIMITED · U
- OvuSense — VIO HEALTHTECH LIMITED · U
- OvuSense — VIO HEALTHTECH LIMITED · U
- OvuSense — VIO HEALTHTECH LIMITED · U
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Vio Healthtech Limited
Sources (1)
- FDA UDI 054d6270-c508-44cf-94e5-4b91e5eb7a33 34 fields · synced Jun 8, 2026