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RIA Testosterone
EUDAMEDClass B (EU MDR)
Ref IM1087Model Immunoassay IM1087Ref IM1119Model Immunoassay IM1119
Identity
- Trade Name
- RIA Testosterone EUDAMEDRIA Testosterone, direct EUDAMED
- Device Name
- RIA Testosterone EUDAMEDRIA Testosterone, direct EUDAMED
- Model / Reference
- Immunoassay IM1087 EUDAMEDIM1087 EUDAMEDImmunoassay IM1119 EUDAMEDIM1119 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590213626 EUDAMED15099590213657 EUDAMED
- Basic UDI-DI
- 150995905IM10875L EUDAMED150995905IM111958 EUDAMED
- EMDN Code
- W0102050110 TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE) 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
RIA Testosterone 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 | 150995905IM10875L | Class B | Active |
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Manufacturer
- Manufacturer
- IMMUNOTECH s.r.o.
- EUDAMED SRN
- CZ-MF-000001761
Sources (2)
- EUDAMED c64a6916-1baf-4732-b343-3b244f50f38f 61 fields · synced Jul 9, 2026
- EUDAMED a680a3cc-4540-4d2b-94af-22feefb7491b 61 fields · synced May 17, 2026