Identity
- Trade Name
- FOLLISCAN EUDAMED
- Device Name
- FOLLISCAN EUDAMED
- Model / Reference
- FOLLISCAN EUDAMEDFOLLISCAN 1.1 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05905090198918 EUDAMED05905090198925 EUDAMED
- Basic UDI-DI
- 59050901989folliclesRZ EUDAMED
- EMDN Code
- Z12080292 GYNAECOLOGY AND FERTILITY TREATMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Poland 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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Folliscan by MIM Fertility Sp. z o.o. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K252332 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 59050901989folliclesRZ | Class IIa | Active |
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Manufacturer
- Manufacturer
- MIM Fertility Sp. z o.o.
- EUDAMED SRN
- PL-MF-000030821
Sources (3)
- EUDAMED c9017d51-1992-4aa3-829b-09fbc463b981 61 fields · synced Jul 31, 2026
- EUDAMED 30e56387-1fee-44b6-96f7-650d130e0b35 61 fields · synced May 18, 2026
- FDA 510(k) K252332 1 fields · synced May 18, 2026