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Fertilitätsmonitor Advanced
EUDAMEDClass IVD devices for self-testing (EU MDR)
Ref 04015600997205Model FAM 1.1
Identity
- Trade Name
- Fertilitätsmonitor Advanced EUDAMED
- Model / Reference
- FAM 1.1 EUDAMED04015600997205 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04015600997205 EUDAMED
- Basic UDI-DI
- B-04015600997205 EUDAMED
- EMDN Code
- W0102160302,W0102160304 EUDAMED
Classification
- Device Class
- Class IVD devices for self-testing EUDAMED
- Market of Registration
- Norway EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
Yes
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
No
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
Fertilitätsmonitor Advanced by Spd Swiss Precision Diagnostics Gmbh — Class IVD devices for self-testing — IVDD — listed in EUDAMED
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-04015600997205 | Class IVD devices for self-testing | Active |
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Manufacturer
- Manufacturer
- SPD Swiss Precision Diagnostics GmbH
- EUDAMED SRN
- CH-MF-000025175
- Authorised Representative
- MDSS GmbH DE-AR-000005430
Sources (1)
- EUDAMED c655312e-bbcb-48ee-8447-bd9cbd604ca8 61 fields · synced Jul 29, 2026