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Tsh Irma Kit
EUDAMEDClass B (EU MDR)
Ref IM3713Model Immunoassay IM3712, IM3713Ref IM3712, IM3713
Identity
- Trade Name
- TSH IRMA KIT EUDAMED
- Device Name
- TSH IRMA KIT EUDAMED
- Model / Reference
- Immunoassay IM3712, IM3713 EUDAMEDIM3713 EUDAMEDIM3712, IM3713 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590220372 EUDAMED15099590220365 EUDAMED
- Basic UDI-DI
- 150995905TSHIRMA2T EUDAMED
- EMDN Code
- W01020410 THYROID 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
Tsh 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 | 150995905TSHIRMA2T | Class B | Active |
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Manufacturer
- Manufacturer
- IMMUNOTECH s.r.o.
- EUDAMED SRN
- CZ-MF-000001761
Sources (3)
- EUDAMED 6772d396-ff8a-4e62-9693-3f6499d75ef9 61 fields · synced Jul 30, 2026
- EUDAMED c875e17f-18bd-4af4-8b7c-9ca5040a4f16 61 fields · synced May 17, 2026
- EUDAMED c875e17f-18bd-4af4-8b7c-9ca5040a4f16-1 61 fields · synced Jun 11, 2026