OraQuick TEST HIV PENTRU AUTOTESTARE

EUDAMED

Class IVD Annex II List A (EU MDR)

Ref 1001-0627

by OraSure Technologies, Inc.

Identity

Trade Name: OraQuick TEST HIV PENTRU AUTOTESTARE EUDAMED
Device Name: OraQuick HIV Self-Test, CE, Romania/Bulgaria, 25-Count Kit EUDAMED
Model / Reference: 1001-0627 EUDAMED

Identifiers

Primary DI / UDI-DI: 10608337001669 EUDAMED
Basic UDI-DI: B-10608337001669 EUDAMED
EMDN Code: W0105090302 HIV 1 / 2 - RT & POC EUDAMED

Classification

Device Class: Class IVD Annex II List A EUDAMED
Market of Registration: Bulgaria EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

EUDAMED

Reagent

EUDAMED

Self Testing

Yes

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

OraQuick TEST HIV PENTRU AUTOTESTARE by OraSure Technologies, Inc. — Class IVD Annex II List A — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	B-10608337001669	Class IVD Annex II List A	Active

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Manufacturer

Manufacturer: OraSure Technologies, Inc.
EUDAMED SRN: US-MF-000009941
Authorised Representative: QbD RepS BV BE-AR-000000040

Sources (1)

EUDAMED 1d03fd14-d771-4189-b439-02eb0d3aa982 61 fields · synced Jul 29, 2026