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OvuSense
FDA UDIEUDAMEDClass U (US FDA UDI)
Ref M426Model M426 OvuFirst Skin Worn Sensor
Identity
- Trade Name
- OvuSense Realtime Fertility Monitor EUDAMEDOvuSense FDA UDI
- Generic Name
- Thermometric fertility analyser FDA UDI
- Device Name
- OvuSense Realtime Fertility Monitor EUDAMEDM426 OvuFirst Skin Worn Sensor FDA UDI
- Model / Reference
- M426 EUDAMEDFDA UDIM426 OvuFirst Skin Worn Sensor EUDAMED
- Description
- M426 OvuFirst Skin Worn Sensor FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05060508530091 EUDAMEDFDA UDI
- Basic UDI-DI
- B-05060508530091 EUDAMED
- FDA Product Code
- LHD FDA UDI
- EMDN Code
- V030199 BODY TEMPERATURE MEASURING DEVICES - OTHER EUDAMED
- GMDN Term
- Thermometric fertility analyser FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDU FDA UDI
- Market of Registration
- Belgium 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
No
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
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 — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — 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 (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class U | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class U | Pending data |
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Manufacturer
- Manufacturer
- Vio Healthtech Limited
Sources (2)
- FDA UDI 42dabd53-e9e9-4540-99c3-857a3517e45c 34 fields · synced Jul 30, 2026
- EUDAMED 1c7ece42-2c72-47bb-b2c9-f338e1c2e2c1 61 fields · synced Jul 30, 2026