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RIA Estradiol

EUDAMED

Class B (EU MDR)

Ref A21854, B89462Model Immunoassay A21854

by IMMUNOTECH s.r.o.

Identity

Trade Name
RIA Estradiol EUDAMED
Device Name
RIA Estradiol EUDAMED
Model / Reference
Immunoassay A21854 EUDAMED
A21854, B89462 EUDAMED

Identifiers

Primary DI / UDI-DI
15099590202132 EUDAMED
Basic UDI-DI
150995905E2RIA7Y EUDAMED
EMDN Code
W0102050103 ESTRADIOL 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 Estradiol 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

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Manufacturer

Manufacturer
IMMUNOTECH s.r.o.
EUDAMED SRN
CZ-MF-000001761

Sources (2)

  • EUDAMED c860dfc1-de18-4712-b148-857f0fc1b5fe 61 fields · synced Jun 18, 2026
  • EUDAMED c860dfc1-de18-4712-b148-857f0fc1b5fe-1 61 fields · synced Jun 11, 2026