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Mh/Uu/Up Realtime Pcr Kit

EUDAMED

Class C (EU MDR)

Ref RTPCR026-LPModel RTPCR026

by Vircell, S.L

Identity

Trade Name
MH/UU/UP REALTIME PCR KIT EUDAMED
Model / Reference
RTPCR026 EUDAMED
RTPCR026-LP EUDAMED

Identifiers

Primary DI / UDI-DI
08436610290128 EUDAMED
Basic UDI-DI
843661029RTPCR026018T 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 C EUDAMED
Market of Registration
Spain 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

Mh/Uu/Up Realtime Pcr Kit by Vircell, S.L — Class C — 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
Vircell, S.L
EUDAMED SRN
ES-MF-000004099

Sources (1)

  • EUDAMED f534e21a-7940-4e8a-89fa-71db6a4cee17 61 fields · synced Jun 17, 2026