Manufacturer

Biobase Diagnostic Technology (Shandong)

ChinaLegal entities : Biobase Diagnostic Technology (Shandong) Co., Ltd.

Markets : Germany

Approvals : EU – class I, A

EU representative : Luxus Lebenswelt GmbH (Germany)

7 categories, 12 models including 12 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Syphilis antibody assays total	W0105010302	Treponema Pallidum Antibody (Anti-TP) Detection Kit（Magnetic Solid Phase ChemiluminescentImmunoassay） 100 Tests/kit98/79 Treponema Pallidum Antibody (Anti-TP) Detection Kit（Magnetic Solid Phase ChemiluminescentImmunoassay） 200 Tests/kit98/79 Treponema Pallidum Antibody (Anti-TP) Detection Kit（Magnetic Solid Phase ChemiluminescentImmunoassay） 50 Tests/kit98/79	– 98/79	EUDAMED record Report an error
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	Cleaning Liquid DR1101 Sample Diluent	A IVDR	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	Biobase COVID-19 Antigen Rapid Test 20 Tests/kit98/79 Biobase COVID-19 Antigen Rapid Test 25 Tests/kit98/79	– 98/79	EUDAMED record Report an error
Samples collection devices - other	W05019099	Disposable Virus Sampling Tube Swab ZD003	I, A IVDR, MDR	EUDAMED record Report an error
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	Automatic Chemiluminescence Immunoassay Analyzer3 refs	A IVDR	EUDAMED record Report an error
Monkeypox virus / mpox - NA reagent	W0105040532	Monkeypox Virus Real Time PCR Kit 50 rxns/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 Kit ZD001	A IVDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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