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Total T3 RIA KIT
EUDAMEDClass B (EU MDR)
Ref D00323Model Immunoassay, D00322, D00323Ref D00322Ref IM3287Model Immunoassay IM1699, IM3287
Identity
- Trade Name
- Total T3 RIA KIT EUDAMED
- Device Name
- Total T3 RIA KIT EUDAMED
- Model / Reference
- Immunoassay, D00322, D00323 EUDAMEDD00323 EUDAMEDD00322 EUDAMEDImmunoassay IM1699, IM3287 EUDAMEDIM3287 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590781699 EUDAMED15099590781682 EUDAMED15099590218850 EUDAMED
- Basic UDI-DI
- 150995905D00322R8 EUDAMED150995905TT3RIAL5 EUDAMED
- EMDN Code
- W01020405 TRIIODOTHYRONINE 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
Yes
EUDAMEDEUDAMED
Total T3 RIA 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 | 150995905D00322R8 | Class B | Active |
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Manufacturer
- Manufacturer
- IMMUNOTECH s.r.o.
- EUDAMED SRN
- CZ-MF-000001761
Sources (3)
- EUDAMED e5e0f3eb-1632-4d13-b348-8929dccb66b2 61 fields · synced Jul 22, 2026
- EUDAMED f75d6d42-a900-42d1-8809-b7af24824739 61 fields · synced May 18, 2026
- EUDAMED 66c5e1e9-7842-4db0-9b56-a88c13aebc2e 61 fields · synced May 18, 2026