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Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Ac…

EUDAMED

Class C (EU MDR)

Ref BSJ02M1Model BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A

by Hangzhou Bioer Technology Co., Ltd.

Identity

Trade Name
Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Acid Detection Kit (Fluorescent PCR) EUDAMED
Device Name
Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Acid Detection Kit EUDAMED
Model / Reference
BSJ02S1, BSJ02M1, BSJ02L1, BSJ02S1A, BSJ02M1A, BSJ02L1A EUDAMED
BSJ02M1 EUDAMED

Identifiers

Primary DI / UDI-DI
06973843227788 EUDAMED
Basic UDI-DI
697384322BSJ02JC EUDAMED
Direct Marketing DI
06973843227788 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
Germany 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

Neisseria gonorrhoeae, Chlamydia trachomatis, Ureaplasma urealyticum Nucleic Ac… by Hangzhou Bioer Technology Co., Ltd. — Class C — IVDR — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

Manufacturer
Hangzhou Bioer Technology Co., Ltd.
EUDAMED SRN
CN-MF-000019512
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (1)

  • EUDAMED 6fb10cdf-65e4-49df-b0c0-881d33a95891 61 fields · synced Jun 18, 2026