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Fsh Irma Kit
EUDAMEDClass B (EU MDR)
Ref IM2125Model Immunoassay IM2125, IM3301Ref IM3301
Identity
- Trade Name
- FSH IRMA KIT EUDAMED
- Device Name
- FSH IRMA KIT EUDAMED
- Model / Reference
- Immunoassay IM2125, IM3301 EUDAMEDIM2125 EUDAMEDIM3301 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590216764 EUDAMED15099590218904 EUDAMED
- Basic UDI-DI
- 150995905FSHIRMATA EUDAMED
- EMDN Code
- W0102050104 FOLLICLE STIMULATING HORMONE EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Czechia EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
Fsh Irma Kit by IMMUNOTECH s.r.o. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 150995905FSHIRMATA | Class B | Active |
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Manufacturer
- Manufacturer
- IMMUNOTECH s.r.o.
- EUDAMED SRN
- CZ-MF-000001761
Sources (2)
- EUDAMED 3ed72ec1-d5dd-4ead-b212-193d4f66f84c 61 fields · synced Jul 30, 2026
- EUDAMED 8fa63c58-29ac-476c-8274-ea9c7397a879 61 fields · synced May 17, 2026