Manufacturer

Chemtronbio

ChinaLegal entities : Shanghai Chemtron Biotech Co., Ltd.

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

EU representative : CMC Medical Devices & Drugs SL (Spain)

6 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
Multiple infectious - multiplex assays - other	W0105070599	COVID-19/Influenza A+B Antigen Combo Rapid Test Cassette98/79 COVID-19/Influenza A+B/RSV Antigen Combo Rapid Test Cassette98/79 COVID-19/Influenza A+B/RSV/ADV Antigen Combo Rapid Test Cassette98/79 COVID-19/Influenza A+B/RSV/ADV/MP Antigen Combo Rapid Test Cassette98/79 RESPIRATORY PATHOGENS ANTIGEN RAPID TEST KIT COV/FLUA +B/ RSV/ ADV/ MP/ HMPV /RhV / PIV1/3/PIV2 Cassette98/79 2 others RESPIRATORY PATHOGENS ANTIGEN RAPID TEST KIT COV/FLUA +B/ RSV/ ADV/ MP/ HMPV /RhV / PIV1/PIV2/PIV3 Cassette98/79 RESPIRATORY PATHOGENS ANTIGEN RAPID TEST KIT COV/FLUA +B/ RSV/ ADV/ MP/ HMPV Cassette98/79	– 98/79	EUDAMED record Report an error
Infectious immunology - other	W0105900299	Chemtrue ® COVID-19/Influenza A+B/RSV Antigen Combo Rapid Test (Colloidal Gold)98/79 Chemtrue ®® COVID-19/Influenza A+B Ag Combo Rapid Test (Colloidal Gold)98/79 Chemtrue ®® COVID-19/Influenza A+B/RSV/ADV Antigen Combo Rapid Test (Colloidal Gold)98/79	– 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	Chemtrue ®® Influenza A+B Antigen Combo Rapid Test (Lateral Flow)98/79 Influenza A+B Antigen Combo Rapid Test 8062C01 Influenza A+B Antigen Combo Rapid Test Cassette 8010C98/79	B IVDR, 98/79	EUDAMED record Report an error
Chlamydia ag - RT & POC	W0105090101	Chlamydia Trachomatis Rapid Test 8001C01P25 Chlamydia Trachomatis Rapid Test Cassette 8001C98/79	C IVDR, 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	Cassette 8022C98/79 HP Ag H.pylori Antigen Rapid Test	B IVDR, 98/79	EUDAMED record Report an error
Virology - RT & POC - other	W0105099099	MULTIPLE RESPIRATORY PATHOGENS ANTIGEN RAPID TEST KIT COV/FLUA +B/ RSV/ ADV/ MP/ HMPV /RhV / PIV1/PIV2/PIV3 / BOV Cassette98/79 RESPIRATORY PATHOGENS ANTIGEN RAPID TEST KIT COV/FLUA +B/ RSV/ ADV/ MP/ HMPV /RhV / PIV1/3/PIV2/BP/SP Cassette98/79	– 98/79	EUDAMED record Report an error

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