Manufacturer

Anbio

ChinaLegal entities : Anbio (Xiamen) Biotechnology Co.,Ltd., Anbio Biotechnology Limited

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

EU representative : Lotus NL B.V. (Netherlands)

15 categories, 22 models including 22 on the market, 1 country

On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Virology - RT & POC - other	W0105099099	Anbio Biotech COVID-19 Antigen Schnelltest (kolloidales Gold) / Nasenabstrich2 refs98/79 BOIRON Rapid COVID-19 Antigen Test (Colloidal Gold)2 refs98/79 BOIRON TEST&CARE COVID-19 AUTOTEST NASAL2 refs98/79 Flu A/B&COVID-19 Antigen&RSV&HMPV Rapid Test Kit A10116001E98/79	– 98/79	EUDAMED record Report an error
Dengue virus	W0105040611	Anbio Dengue NS1 Ag&IgG/IgM Rapid Test Kit98/79 Dengue IgM/IgG Rapid Test Kit A1000400198/79 Dengue NS1 Rapid Test Kit98/79	– 98/79	EUDAMED record Report an error
Immunochemistry instruments - other	W02010299	Anbio AF-100, AF-100S, AF-100C, AF-12003 refs Anbio Biotechnology AF-100, AF-100S, AF-100C, AF-12003 refs	A IVDR	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	BOIRON A10013001D98/79 Group A Streptococcus Test Kit A0216700298/79	– 98/79	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	Anbio	A IVDR	EUDAMED record Report an error
Chemistry analysers - moderate routine (random access without ise mode test/h > 400 and <= 800)	W0201010102	SHA-100, SHA-200	A IVDR	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer Rapid Test Kit A0200800298/79	– 98/79	EUDAMED record Report an error
Glycosilated hemoglobin devices	W0201060101	HbA1c Rapid Test Kit98/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	Anti-HP Rapid Test Kit A0208200298/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	HP Rapid Test Kit A0208100298/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A/B Rapid Test Kit A0210500298/79	– 98/79	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	IL-6 Rapid Test Kit A0201400298/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria)	W0105050209	Malaria (Pf/Pv) Rapid Test Kit A0208300298/79	– 98/79	EUDAMED record Report an error
Respiratory syncytial virus (rsv)	W0105040605	RSV Ag Rapid Test Kit A0210800298/79	– 98/79	EUDAMED record Report an error
Viral antigen/antibody detection - other	W0105040699	RV/AV Rapid Test Kit A10029001E98/79	– 98/79	EUDAMED record Report an error

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