Manufacturer

Sejoy

ChinaLegal entities : Sejoy Biomedical Co., Ltd.

First countries of placing on the market declared in EUDAMED : Czechia, France, Germany, Greece, Poland, Spain

EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)

17 categories, 41 models including 41 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
Blood glucose meters	W0201060102	BG-201 Blood Glucose Monitoring System98/79 Blood Glucose Monitoring system BG-70798/79 Blood Glucose Monitoring system BG-713t Ease98/79 Sejoy BG-709g98/79 SEJOY Blood Glucose Monitoring System BG-20198/79 8 others SEJOY Blood Glucose Monitoring System BG-201 (100S)98/79 SEJOY Blood Glucose Monitoring System BG-201 (50S)98/79 SEJOY Blood Glucose Monitoring System BG-202 （BLU）98/79 SEJOY Blood Glucose Monitoring System BG-20398/79 SEJOY Blood Glucose Monitoring System BG-709 Blood Glucose Monitoring System98/79 SEJOY Blood Glucose Monitoring System BG-709 （50S）98/79 SEJOY Blood Glucose Monitoring System BG-710b98/79 SEJOY Blood Glusose Monitoring system BG-20298/79	– 98/79	EUDAMED record Report an error
Virology - RT & POC - other	W0105099099	COIF-52298/79 ISIR-933498/79 SARS-CoV-2 & Influenza A/B & RSV Antigen Combo Test Kit98/79 SARS-CoV-2 Antigen Rapid Test Cassette98/79 SARS-CoV-2 Antigen Rapid Test Cassette COVG-60298/79	– 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Dengue IgG/IgM Rapid Test Device Cassette98/79 Dengue IgG／IgM／NS1 Combo Rapid Test Cassette98/79 Dengue NS1 Antigen Rapid Test Cassette98/79	– 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	ISIRA-944598/79 ISIRAH-965598/79 SARS-CoV-2 & Influenza A/B & Respiratory Syncytial Virus & HMPV Antigen Combo Test Kit98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Malaria P.f ＆P.v Rapid Test (Whole Blood) Cassette98/79 Malaria P.f ＆Pan Rapid Test (whole blood) Cassette98/79 Malaria Plasmodium Falciparum Rapid Test (whole blood) Cassette98/79	– 98/79	EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	BF-101 BF-102 LPM-101,LPM-1022 refs	C IVDR	EUDAMED record Report an error
Adenovirus	W0105040601	Adenovirus Rapid Test (Feces) Cassette98/79	– 98/79	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test Cassette98/79	– 98/79	EUDAMED record Report an error
Coronavirus ag	W0105041101	SARS-CoV-2 & Influenza A+B Antigen Combo Rapid Test COIF-52298/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	H.pylori Antibody Rapid Test Cassette98/79	– 98/79	EUDAMED record Report an error
Haemoglobin (hb)	W0103010601	Hemoglobin Test Strip HS-10198/79	– 98/79	EUDAMED record Report an error
Haemoglobin controls	W0103010504	Hemoglobin Monitoring control solution HC-10198/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Influenza A+B Rapid Test Cassette98/79	– 98/79	EUDAMED record Report an error
Rapid test hematology / histology / cytology instruments - other	W02020699	Hemoglobin Monitoring meter HB-101.HB-201,HB-20298/79	– 98/79	EUDAMED record Report an error
Salmonella antibody assays	W0105011002	Typhoid IgG/IgM Rapid Test Cassette98/79	– 98/79	EUDAMED record Report an error
Strep. a detection by NA reagents	W0105011103	Strep A Rapid Test ISTA-811298/79	– 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	Syphilis Antibody Rapid Test Cassette,Strip98/79	– 98/79	EUDAMED record Report an error

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