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Step 2 Plates for Urinogenital and Resistance 12 well

EUDAMED

Class IVD Annex II List B (EU MDR)

Ref 27123PModel Multiple sexually transmitted pathogen (Annex II) nucleic acid IVD, reagentRef 87123P

by AusDiagnostics Pty Ltd

Identity

Trade Name
Step 2 Plates for Urinogenital and Resistance 12 well EUDAMED
Step 2 Plates for Urinogenital and Resistance 12-well EUDAMED
Device Name
Step 2 Plates for Urinogenital and Resistance 12 well EUDAMED
Step 2 Plates for Urinogenital and Resistance 12-well EUDAMED
Model / Reference
Multiple sexually transmitted pathogen (Annex II) nucleic acid IVD, reagent EUDAMED
27123P EUDAMED
87123P EUDAMED

Identifiers

Primary DI / UDI-DI
09343044002854 EUDAMED
09343044004933 EUDAMED
Basic UDI-DI
B-09343044002854 EUDAMED
B-09343044004933 EUDAMED
EMDN Code
W0105070501 STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS EUDAMED

Classification

Device Class
Class IVD Annex II List B EUDAMED
Market of Registration
Italy 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

Step 2 Plates for Urinogenital and Resistance 12 well by AusDiagnostics Pty Ltd — Class IVD Annex II List B — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

Manufacturer
AusDiagnostics Pty Ltd
EUDAMED SRN
AU-MF-000020558
Authorised Representative
R-Biopharm AG DE-AR-000050025

Sources (2)

  • EUDAMED a683b50f-8cf5-4526-85ae-aafd3665af67 61 fields · synced Oct 5, 2026
  • EUDAMED c597f892-f190-4d86-a167-258856f0d2cf 61 fields · synced May 19, 2026