Manufacturer

Lysunbio

ChinaLegal entities : Hangzhou Lysun Biotechnology Co., Ltd

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

EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain)

18 categories, 33 models including 33 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
Various rapid test chemistry / immunochemistry instruments - IVD medical device software	W0201069092	BHS-101(25 PCS)98/79 GUC-101 GUC-102 GUK-101 LYSUN GULP-101 3 others LYSUN GULP-102 LYSUN GUM-101 TCM-101	A IVDR, 98/79	EUDAMED record Report an error
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	LYSUN GUKC-101 LYSUN GUKC-102 LYSUN RFM-101 LYSUN RFM-201 RFS-101（25 PCS)98/79	A IVDR, 98/79	EUDAMED record Report an error
Rapid test hematology / histology / cytology instruments - other	W02020699	BHS-201(25 PCS)98/79 Hemoglobin Analysis Meter BHM-202 LYSUN BHM-102	A IVDR, 98/79	EUDAMED record Report an error
Blood glucose meters	W0201060102	BGM-10198/79 LYSUN BGM-103N98/79	– 98/79	EUDAMED record Report an error
Salmonella detection by NA reagents	W0105011003	LYSUN SAL-F21(25PCS)98/79 LYSUN TYP-P21（25PCS）98/79	– 98/79	EUDAMED record Report an error
Astrovirus	W0105040629	LYSUN Gon-102（25PCS）98/79	– 98/79	EUDAMED record Report an error
D-dimer	W0103020503	LYSUN DIM-W21（25PCS）98/79	– 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	LYSUN DEG-P21（25PCS）98/79	– 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	LYSUN HP-F21（25PCS）98/79	– 98/79	EUDAMED record Report an error
Haemoglobin (hb)	W0103010601	LYSUN BHM-202	A IVDR	EUDAMED record Report an error
Hav antibody (total)	W0105020102	LYSUN HAV-W21-GM（25PCS）98/79	– 98/79	EUDAMED record Report an error
Immunochemistry instruments - other	W02010299	Influenza A+B/COVID-19/ RSV Antigen Rapid Test98/79	– 98/79	EUDAMED record Report an error
Influenza & para influenza - NA reagents	W0105040504	LYSUN FLU-S21（25PCS）98/79	– 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	LYSUN MAL-W21- FV（25PCS）98/79	– 98/79	EUDAMED record Report an error
Protein c	W0103020607	LYSUN CRP-W21-1(25PCS)98/79	– 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	LYSUN STP-S21（25PCS）98/79	– 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	LYSUN SYP-W21（25PCS）98/79	– 98/79	EUDAMED record Report an error
Viral antigen/antibody detection - other	W0105040699	LYSUN TB-W21（25PCS）98/79	– 98/79	EUDAMED record Report an error

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