Manufacturer

Anhui Formaster Biosci

ChinaLegal entities : Anhui Formaster Biosci Co., Ltd.

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

EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)

17 categories, 19 models including 19 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
Other multiple pathogens - RT & POC	W0105090699	Influenza A&B/Adeno/RSV/COVID-19 Antigen98/79 Influenza A&B/Adeno/RSV/COVID-19/MP Antigen Rapid Test98/79 Influenza A&B/RSV/COVID-19 Antigen Rapid Test98/79	– 98/79	EUDAMED record Report an error
Adenovirus	W0105040601	Adenovirus Rapid Test (Feces) IAD-301398/79	– 98/79	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	Influenza A&B/COVID-19 Antigen Combo Rapid Test98/79	– 98/79	EUDAMED record Report an error
Dengue virus	W0105040611	Dengue Ab and Ag Combo Rapid Test Cassette (Whole Blood/Serum/Plasma) IDEC-502398/79	– 98/79	EUDAMED record Report an error
Gonococcal antigen detection	W0105010201	Gonorrhea Rapid Test (Swab) WGO-101398/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	H. pylori Antigen Rapid Test (Feces) IHP-301398/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	H. pylori Antibody Rapid Test (Whole Blood/Serum/Plasma) IHP-501398/79	– 98/79	EUDAMED record Report an error
Hav antibody (total)	W0105020102	HAV Rapid Test Cassette (Serum/Plasma) IHA-601398/79	– 98/79	EUDAMED record Report an error
Hepatitis viruses - RT & POC - other	W0105090299	HEV IgG/IgM Rapid Test (Serum/Plasma) IHE-601398/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza	W0105040604	Influenza A&B Rapid Test IIN-102398/79	– 98/79	EUDAMED record Report an error
Norovirus	W0105040616	NORO (Norovirus) Rapid Test (Feces)98/79	– 98/79	EUDAMED record Report an error
Rotavirus	W0105040606	Rotavirus Rapid Test (Feces) IRO-301398/79	– 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	RSV Rapid Test IRS-101398/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	Strep A Rapid Test (Swab) ISA-101398/79	– 98/79	EUDAMED record Report an error
Strep. b - RT & POC	W0105090104	Strep B Rapid Test (Swab) ISB-101398/79	– 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	Syphilis Rapid Test (Whole Blood/Serum/Plasma) ISY-501398/79	– 98/79	EUDAMED record Report an error
Viral antigen/antibody detection - other	W0105040699	Rotavirus/Adenovirus Combo Rapid Test Cassette (Feces) IRA-302398/79	– 98/79	EUDAMED record Report an error

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