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OvuSense Realtime Fertility Monitor
EUDAMEDClass IIa (EU MDR)
Ref M400WModel M400W OvuSense Starter Kit (OvuFirst Skin Worn Sensor with wrist band)
Identity
- Trade Name
- OvuSense Realtime Fertility Monitor EUDAMED
- Device Name
- OvuSense Realtime Fertility Monitor EUDAMED
- Model / Reference
- M400W OvuSense Starter Kit (OvuFirst Skin Worn Sensor with wrist band) EUDAMEDM400W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05060508530138 EUDAMED
- Basic UDI-DI
- B-05060508530138 EUDAMED
- EMDN Code
- V030199 BODY TEMPERATURE MEASURING DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
OvuSense Realtime Fertility Monitor by viO HealthTech Limited — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05060508530138 | Class IIa | Active |
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Manufacturer
- Manufacturer
- viO HealthTech Limited
- EUDAMED SRN
- GB-MF-000008062
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (1)
- EUDAMED a6e32620-7f58-474a-8bcb-3f14202dd551 61 fields · synced Jul 12, 2026