Manufacturer

Shanghai BioGerm Medical Technology

ChinaLegal entities : Shanghai BioGerm Medical Technology Co., Ltd.

First countries of placing on the market declared in EUDAMED : Germany, Spain

EU representative : Medunion S.L. (Spain)

9 categories, 39 models including 39 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Virology - RT & POC - other	W0105099099	Enterovirus Universal Nucleic Acid Detection Kit(PCR-Fluorescence Probing) 25 tests/kit98/79 Enterovirus Universal Nucleic Acid Detection Kit(PCR-Fluorescence Probing) 50 tests/kit98/79 Enterovirus Universal Nucleic Acid Detection Kit(PCR-Fluorescence Probing) 96 tests/kit98/79 Influenza A/B virus Antigen Rapid Test Kit 1 test/kit98/79 Influenza A/B virus Antigen Rapid Test Kit 20 tests/kit98/79 16 others Influenza A/B virus Antigen Rapid Test Kit 5 tests/kit98/79 Influenza A/B virus Antigen Rapid Test Kit 50 tests/kit98/79 Mycoplasma pneumoniae IgM Antibody Rapid Test Kit 1 test/kit98/79 Mycoplasma pneumoniae IgM Antibody Rapid Test Kit 20 test/kit98/79 Mycoplasma pneumoniae IgM Antibody Rapid Test Kit 5 tests/kit98/79 Mycoplasma pneumoniae IgM Antibody Rapid Test Kit 50 tests/kit98/79 Nipah virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 25 tests/kit98/79 Nipah virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 50 tests/kit98/79 SARS-CoV-2 /Flu A / Flu B/RSV/ADV/MP Antigen Rapid Test Kit 1 test/kit98/79 SARS-CoV-2 /Flu A / Flu B/RSV/ADV/MP Antigen Rapid Test Kit 20 tests/kit98/79 SARS-CoV-2 /Flu A / Flu B/RSV/ADV/MP Antigen Rapid Test Kit 5 tests/kit98/79 SARS-CoV-2 /Flu A / Flu B/RSV/ADV/MP Antigen Rapid Test Kit 50 tests/kit98/79 SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit 1 test/kit98/79 SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit 20 tests/kit98/79 SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit 5 Tests/kit98/79 SARS-CoV-2 /Influenza A/B virus antigen Rapid Test kit 50 tests/kit98/79	– 98/79	EUDAMED record Report an error
IVD instruments - other	W0299	Automatic Nucleic Acid Purification Instrument BG-Flex-32 Automatic Nucleic Acid Purification Instrument BG-Star-96 Automatic Nucleic Acid Purification Instrument E-96 Fully Automated Nucleic Acid Analyzer BG-X6 Nucleic Acid Isothermal Amplification Detection Analyzer BG-Nova-X8	A IVDR	EUDAMED record Report an error
Influenza & para influenza - NA reagents	W0105040504	6-in-1 Respiratory Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 50 tests/kit98/79 Influenza A/B & RSV Nucleic Acid Detection Kit (Fluorescent RT-MIRA) 24 tests/kit Sampling tube with 0.75mL Lysis Buffer98/79 Influenza A/B & RSV Nucleic Acid Detection Kit (Fluorescent RT-MIRA) 24 tests/kit Sampling tube with 2.5mL Lysis Buffer98/79 Respiratory Syncytial Virus/HumanParainfluenza Virus /Human Rhinovirus Nucleic Acid Detection Kit (Fluorescent RT-MIRA) 24 tests/kit98/79	– 98/79	EUDAMED record Report an error
Coronavirus - NA reagents	W0105041106	Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 50 tests/ kit98/79 Novel Coronavirus (2019-nCoV) Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 96 tests/ kit98/79 Novel Coronavirus (SARS-CoV-2) Nucleic Acid Detection Kit (Fluorescent RT-MIRA) 24 Tests/Kit;2 refs98/79	– 98/79	EUDAMED record Report an error
Coronavirus antibodies - total	W0105041102	Diagnostic Kit for 2019-nCoV Antigen (Colloidal Gold) 20 Tests/kit98/79 Diagnostic Kit for 2019-nCoV Antigen (Colloidal Gold) 50 Tests/kit98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A/B Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 50 tests/kit98/79	– 98/79	EUDAMED record Report an error
Norovirus - NA reagents	W0105040516	Norovirus Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 50 tests/kit98/79	– 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Nucleic acid extraction and purification kit 96 tests/ kit2 refs	A IVDR	EUDAMED record Report an error
Virology - NA reagents - other	W0105040599	Monkeypox Virus Nucleic Acid Detection Kit (PCR-Fluorescence Probing) 25 tests/kit ;2 refs	C IVDR	EUDAMED record Report an error

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