Identity
- Trade Name
- femSense Fertility EUDAMED
- Device Name
- femSense EUDAMED
- Model / Reference
- 09120095900502 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120095900502 EUDAMED
- Basic UDI-DI
- 912009590FEM012L EUDAMED
- Direct Marketing DI
- 09120095900502 EUDAMED
- EMDN Code
- V0399 MEASUREMENT DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
femSense Fertility by SteadySense GmbH — 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 | 912009590FEM012L | Class I | Active |
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Manufacturer
- Manufacturer
- SteadySense GmbH
- EUDAMED SRN
- AT-MF-000003984
Sources (1)
- EUDAMED cf19639e-65cd-47ff-adf5-8cdd3f676a3a 61 fields · synced Jun 18, 2026