Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Prob…

EUDAMED

Class IVD General (EU MDR)

Ref ZC-HX-201-3Model 96 tests/ kitRef ZC-HX-201-2Model 50 tests/ kit

by Shanghai BioGerm Medical Technology Co., Ltd.

Identity

Trade Name: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) EUDAMED
Device Name: Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) EUDAMED
Model / Reference: 96 tests/ kit EUDAMED
ZC-HX-201-3 EUDAMED
50 tests/ kit EUDAMED
ZC-HX-201-2 EUDAMED

Identifiers

Primary DI / UDI-DI: 06974677690281 EUDAMED
06974677690274 EUDAMED
Basic UDI-DI: B-06974677690281 EUDAMED
B-06974677690274 EUDAMED
EMDN Code: W0105900102 REAGENTS FOR DNA AND/OR RNA AMPLIFICATION AND/OR DETECTION: BACTERIA AND/OR VIRUS EUDAMED

Classification

Device Class: Class IVD General EUDAMED
Market of Registration: Germany EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

Yes

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Prob… by Shanghai BioGerm Medical Technology Co., Ltd. — Class IVD General — IVDD…

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-06974677690281	Class IVD General	Active

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Manufacturer

Manufacturer: Shanghai BioGerm Medical Technology Co., Ltd.
EUDAMED SRN: CN-MF-000018164
Authorised Representative: PureMDR GmbH DE-AR-000007923

Sources (2)

EUDAMED cfa6fcf9-7e48-4c84-826a-3d4b5d25188a 61 fields · synced Oct 6, 2026
EUDAMED 62045bbb-4262-48a4-ad05-7ba9632bfd5c 61 fields · synced May 17, 2026