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femSense Fertility
EUDAMEDClass I (EU MDR)
Ref 09120095900519Ref 09120095900250Ref 09120095900052
Identity
- Trade Name
- femSense Fertility EUDAMEDfemSense EUDAMED
- Device Name
- femSense EUDAMED
- Model / Reference
- 09120095900519 EUDAMED09120095900250 EUDAMED09120095900052 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120095900519 EUDAMED09120095900250 EUDAMED09120095900052 EUDAMED
- Basic UDI-DI
- 912009590FEM012L EUDAMED
- Direct Marketing DI
- 09120095900519 EUDAMED09120095900250 EUDAMED09120095900052 EUDAMED
- EMDN Code
- V0399 MEASUREMENT DEVICES - OTHER EUDAMEDW0102160399 FERTILITY/PREGNANCY RT & POC - 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 (3)
- EUDAMED ee8b3040-a0d4-47d7-8f1a-92b6cf5e79ed 61 fields · synced Jul 15, 2026
- EUDAMED efb281f5-a5ee-4ae9-bbe2-a3456e18ce4c 61 fields · synced May 19, 2026
- EUDAMED fbac617a-fefb-4f17-af91-f74dafe5d8a7 61 fields · synced May 19, 2026