Manufacturer

Assure Tech. (Hangzhou)

ChinaLegal entities : Assure Tech. (Hangzhou) Co., Ltd.

Markets : Austria · Germany · Netherlands · Spain

Approvals : EU – class A, B, C

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

Website contact@diareagent.com

53 categories, 157 models including 157 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Various rapid test chemistry / immunochemistry instruments - other	W0201069099	Automatic Chemiluminesence Immunoanalyzer CLI1000, CLI1000X Blood Cholesterol Monitoring Systems (Blood Cholesterol Meter, Test Strip) CML-101,MLS-10198/79 Blood Glucose and Hemoglobin Test Meter GHE-101 Blood Glucose and Uric Acid Test Meter GUE-101 Blood Glucose and β-Ketone Test Meter GKE-101 19 others Blood Glucose Test Meter GOH-101Pro Blood Glucose and Uric Acid and Total Cholesterol Test Meter GUC-101 Colloidal Gold Test Analyzer ACG1000 Colloidal Immunoassay Analyzer ADT100 DOA Cup Reader ADT200，ADT201 Fluorescence Immunoassay Analyzer AFI 6100B Fluorescence Immunoassay Analyzer TFL1000 Fully Automatic Biochemistry Analyzer AS-60C G6PD and Hemoglobin Biosensor Test Meter GPHB-101 G6PD Biosensor Test Meter G6PD-101 Handheld DOA Reader ADT 2000 Handheld DOA Reader ADT3000 Hemoglobin Test Meter AS-XH-02 Lactate Test Meter LAC-101 Multi-functional Monitor MSE-101 Multi-functional MonitorⅠ MSE-100 Portable Coagulation Analyzer AS-150C Portable Glycosylated Hemoglobin Analyzer HbA1c-101 Semi-Automatic Fluorescence Immunassay Analyzer AFI 5300	A IVDR, 98/79	EUDAMED record Report an error
Virology - RT & POC - other	W0105099099	Adenovirus Rapid Test98/79 Adenovirus Respiratory Test98/79 Chagas Antibody Rapid Test CHA-W2398/79 Chikungunya IgG/IgM Rapid Test CHKV-W2398/79 COVID-19 Antigen FIA COV-S23F398/79 17 others COVID-19 Antigen Nasal Test Kit COV-S35002H98/79 COVID-19 Antigen Rapid Test Device Device 1 person/box98/79 COVID-19 Antigen Rapid Test Format (cassette): A4791511 A47915120 A47915140 A4791521 A47915220 A47915240 Format (pen): A4841011 A48410120 A4841021 A48410220 COVID-19 Antigen Saliva Test Kit98/79 COVID-19 Antigen Saliva Test Kit kit 3pcs/box98/79 COVID-19 Neutralizing Antibody Rapid Test COV-W2300198/79 COVID-19&FLU A/B FIA MI-S22MF398/79 COVID-19 & Influenza A/B Antigen Nasal Test Kit 1 pcs/kit98/79 COVID-19 IgG Rapid Test COV-W2300298/79 COVID-19 IgG Test Kit COV-W3598/79 Measles IgG/IgM Rapid Test MEV-W23M98/79 Norovirus GI+GII Rapid Test98/79 Norovirus GI+GII Rapid Test Format (cassette): A4B27111 A4B271125 A4B271140 A4B27121 A4B271225 A4B271240 Respiratory Syncytial Virus Rapid Test98/79 Rotavirus and Adenovirus Combo Rapid Test Format (cassette): A4A23011 A4A230125 A4A230140 A4A23021 A4A230225 A4A230240 SARS-CoV-2 Antigen Rapid Tests for Self-Testing Device 1 person/box98/79 Zika NS1 Antigen Rapid Test98/79	B IVDR, 98/79	EUDAMED record Report an error
Other multiple pathogens - RT & POC	W0105090699	C. difficile Toxin A/B Rapid Test Format (cassette): A4A93011 A4A930125 A4A930140 A4A93021 A4A930225 A4A930240 COVID-19 & Influenza A/B & RSV & ADV & HMPV Antigen Combo Test COVID-19 & Influenza A/B & RSV Antigen Combo Rapid Test98/79 COVID-19& Influenza A/B& RSV Antigen Combo Test Format (cassette): A4981011 A49810120 A49810140 A4981021 A49810220 A49810240 Format (pen): A4776011 A47760120 A4776021 A47760220 COVID-19&Influenza A/B Antigen combo Test Format (cassette): A4943011 A49430120 A49430140 A4943021 A49430220 A49430240 Format (pen): A4766011 A47660120 A4766021 A47660220 11 others COVID-19&Influenza A/B&RSV&ADV Antigen combo Test Format (cassette): A4933011 A49330120 A49330140 A4933021 A49330220 A49330240 Format (pen): A4956011 A49560120 A4956021 A49560220 COVID-19&Influenza A/B&RSV&ADV&MP Antigen combo Test Format (cassette): A4923011 A49230120 A49230140 A4923021 A49230220 A49230240 Format (pen): A4D56011 A4D560120 A4D56021 A4D560220 COVID-19&Influenza A/B&RSV&ADV&MP&HMPV Antigen combo Test Format (cassette): A4D73011 A4D730120 A4D730140 A4D73021 A4D730220 A4D730240 COVID-19&Influenza A/B&RSV&ADV&MP&HMPV&HPIV Antigen combo Test Format (cassette): A4D83011 A4D830120 A4D830140 A4D83021 A4D830220 A4D830240 FLU A/FLU B/RSV/ADV/MP/COVID-19 Combo Test98/79 Influenza A/B & RSV & ADV Antigen Combo Test Influenza A/B & RSV Antigen Combo Test A4C83011 Influenza A/B&ADV Antigen combo Test Format (cassette): A4D33011 A4D330120 A4D330140 A4D33021 A4D330220 A4D330240 Format (pen): A4D36011 A4D360120 A4D36021 A4D360220 Rotavirus-Adenovirus-Astrovirus-Norovirus Combo Test A4B630 Rotavirus-Adenovirus-Astrovirus-Norovirus Combo test AT-MI-F4400198/79 Rotavirus-Adenovirus-Norovirus Combo Test Format (cassette): A4A13011 A4A130125 A4A130140 A4A13021 A4A130225 A4A130240	B IVDR, 98/79	EUDAMED record Report an error
Bacteriology - RT & POC - other	W0105090199	Crypto/Giardia combo Test98/79 Cryptococcus Rapid Test98/79 Cryptosporidium Test Crypto-F2398/79 Device A438711252 refs Device A43910125 6 others Device A4B31011 Device A4B370125 Giardia lamblia Test GL-F2398/79 Rickettsia Test RICK-W2398/79 S. pneumoniae Rapid Test Device (Urine) SPN-U2398/79 Tuberculosis Rapid Test Device (Whole Blood/Serum/Plasma)98/79	C IVDR, 98/79	EUDAMED record Report an error
Plasmodium (malaria) - RT & POC	W0105090401	Device A4343011 Device A4347011 Device A4353011 Device A4357011 Malaria P.f Rapid Test Mal pf-W11M, Mal pf-W23M98/79 2 others Malaria P.f/Pan Rapid Test Mal pf/pan-W11M,Mal pf/pan-W23M98/79 Malaria pf/pv Rapid Test Mal pf/pv-W11M, Mal pf/pv-W23M98/79	C IVDR, 98/79	EUDAMED record Report an error
Adenovirus	W0105040601	Adenovirus Antigen Feces Rapid Test A49830125, A49830225 Adenovirus Antigen Nasal Rapid Test A46410120, A46410220 Adenovirus FIA ADV-F23F398/79 ADV FIA ADV-S23F398/79	B IVDR, 98/79	EUDAMED record Report an error
H. pylori - RT & POC	W0105090102	H. pylori Antibodies Rapid Test HP-P11, HP-P23, HP-W11, HP-W2398/79 H. pylori Antibodies Rapid Test HP-W2398/79 H. pylori Antibody FIA HP-W23F398/79 H. pylori Antigen FIA HP-F23F398/79	– 98/79	EUDAMED record Report an error
Virology reagents - other	W01050499	E. histolytica & Giardia lamblia & Crypto Combo Rapid Test Kit MI-F4300198/79 FLUA-FLUB-RSV-ADV-COVID-19 Combo Test Device MI-S4500198/79 Rotavirus-Adenovirus-Norovirus Combo test MI-F4300398/79 Rotavirus/Adenovirus/Norovirus/Astrovirus Combo Test MI-F4400198/79	– 98/79	EUDAMED record Report an error
Blood glucose meters	W0201060102	AcuteckTM Blood Glucose Monitoring System3 refs Blood Glucose Monitoring Systems (Blood Glucose Meter, Test Strip) EG-101，EG-102，EGS-10198/79 Blood Glucose Test Strips C90100598/79	C IVDR, 98/79	EUDAMED record Report an error
D-dimer - RT & POC	W0103020803	D-Dimer Chemiluminescence Immunoassay Test Kit98/79 D-Dimer FIA DDM-W23F398/79 Device A1061011	C IVDR, 98/79	EUDAMED record Report an error
Dengue - RT & POC	W0105099007	Dengue Rapid Test Den-W23M NS1-W2398/79 Device A4291011 Device A4303011	C IVDR, 98/79	EUDAMED record Report an error
Influenza a and /or b - RT & POC	W0105099004	FLU A/B FIA FLU-S23F398/79 Influenza A/B Rapid Test Device A46071120,A46071220 Influenza A/B Rapid Test FLU-S23M98/79	B IVDR, 98/79	EUDAMED record Report an error
Strep. a - RT & POC	W0105090103	STA FIA STA-S23F398/79 Strep A Rapid Test Device Strip, Device A46310113 refs Strep A Rapid Test STA-S2398/79	B IVDR, 98/79	EUDAMED record Report an error
Syphilis - RT & POC	W0105090105	Device A41511125 Syphilis FIA SYP-W23F398/79 Syphilis Rapid Test SYP-P11, SYP-P23, SYP-W11, SYP-W2398/79	C IVDR, 98/79	EUDAMED record Report an error
Astrovirus	W0105040629	Astrovirus FIA ASV-F23F398/79 Astrovirus Test ASV-F2398/79	– 98/79	EUDAMED record Report an error
C.difficile GDH and toxin a/b combined detection	W0105011803	C. difficile Toxin A FIA CDF A-F23F398/79 C. difficile Toxin B FIA CDF B-F23F398/79	– 98/79	EUDAMED record Report an error
H. pylori antigen detection	W0105010401	H. pylori Antigen Rapid Test A4A412125,A4A412225 H. pylori Antigens Rapid Test HP-F2398/79	B IVDR, 98/79	EUDAMED record Report an error
Hepatitis viruses - RT & POC - other	W0105090299	Device A4C410125 Hepatitis A Virus IgG/IgM Test Kit HAV-W35M, HAV-P23M98/79	C IVDR, 98/79	EUDAMED record Report an error
Rotavirus	W0105040606	Rotavirus Antigen Rapid Test A49930125, A49930225 Rotavirus FIA ROTA-F23F398/79	B IVDR, 98/79	EUDAMED record Report an error
Rsv - RT & POC	W0105099002	RSV Antigen Nasal test Kit RSV-W3598/79 RSV FIA RSV-S23F398/79	– 98/79	EUDAMED record Report an error
Salmonella antigen detection	W0105011001	Faecal Occult Blood Fecal Test Kit FOB-F11, FOB-F23, FOB-F4398/79 Typhoid Rapid Test TYP-F23, TYP-W2398/79	– 98/79	EUDAMED record Report an error
Strep. b - RT & POC	W0105090104	Device A45910120 Strep B Rapid Test STB-S2398/79	C IVDR, 98/79	EUDAMED record Report an error
Bacteriology immunoassay - other	W0105011799	Cholera O1 Antigen Fecal Test Kit VCO1-F2398/79	– 98/79	EUDAMED record Report an error
Brucella	W0105011701	Brucella Antiboby Test BRU-W2398/79	– 98/79	EUDAMED record Report an error
Buffers (unassignable ), supplem. reagents, etc	W0105900201	Fecal Occult Blood Buffer FOB-B001	A IVDR	EUDAMED record Report an error
C.difficile GDH detection	W0105011801	C. difficile GDH Rapid Test GDH-F2398/79	– 98/79	EUDAMED record Report an error
Campylobacter direct antigen detection	W0105011401	Campylobacter Rapid Test CAM-F2398/79	– 98/79	EUDAMED record Report an error
Chlamydia ag - RT & POC	W0105090101	Device A40110120	C IVDR	EUDAMED record Report an error
Clost. diff. incl GDH and/or toxin a and b - RT & POC	W0105090106	C. difficile GDH FIA GDH-F23F398/79	– 98/79	EUDAMED record Report an error
Coronavirus / influenza - RT & POC	W0105090601	Fastep MI-S33001H598/79	– 98/79	EUDAMED record Report an error
Coronavirus antigen (ag) - RT & POC	W0105090501	Device COV-S23004H198/79	– 98/79	EUDAMED record Report an error
Dengue virus	W0105040611	Dengue Rapid Test Format (cassette): A4287011 A42870125 A42870140 A4287021 A42870225 A42870240	B IVDR	EUDAMED record Report an error
E. coli reagents - other	W0105011599	E. coli O157 Rapid Test ECO-F2398/79	– 98/79	EUDAMED record Report an error
Glycosilated hemoglobin devices	W0201060101	Hemoglobin Test Strips and Hemoglobin Meter AS-XH-02,HBM-W1198/79	– 98/79	EUDAMED record Report an error
Gonococcal antibody assays total	W0105010202	Gonorrhea Rapid Test GON-S2398/79	– 98/79	EUDAMED record Report an error
H. pylori antibody assays	W0105010402	H. pylori Antibody Rapid Test Format (cassette): A4A411125, A4A411140, A4A411225, A4A411240 Format (strip): A4A410150, A4A410250	B IVDR	EUDAMED record Report an error
Hav antibody igm	W0105020104	HAV IgM Rapid Test A40310125, A40310140, A40310225, A40310240	B IVDR	EUDAMED record Report an error
HIV 1 / 2 - RT & POC	W0105090302	HIV1/2 Human Immunodeficiency Virus Rapid Test Device (Whole Blood/Serum/Plasma)98/79	– 98/79	EUDAMED record Report an error
Immunochemistry instruments - other	W02010299	Handheld Fluorescence Immunoassay Analyzer	A IVDR	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	Interleukin-6 FIA IL6-W23F398/79	– 98/79	EUDAMED record Report an error
Legionella - RT & POC	W0105090108	Legionella Antigen Rapid Test Device (Urine) LEG-U2398/79	– 98/79	EUDAMED record Report an error
Limited panel chemistry analysers - hardware accessories	W0201010280	Fully Automatic Chemiluminescence analyzer	A IVDR	EUDAMED record Report an error
Multiple viruses - other	W01050799	Rotavirus＆Adenovirus Antigen Fecal Combo Test Kit MI-F4200198/79	– 98/79	EUDAMED record Report an error
Mycoplasma antigen detection	W0105010801	Mycoplasma pneumoniae Antigen Rapid Test MP-S2398/79	– 98/79	EUDAMED record Report an error
Norovirus	W0105040616	Norovirus FIA NOV-F23F398/79	– 98/79	EUDAMED record Report an error
Other coronavirus - RT & POC	W0105090599	COVID 19 Rapid Test98/79	– 98/79	EUDAMED record Report an error
Parasites - RT & POC - other	W0105090499	Giardia lamblia Rapid Test Format (cassette): A4B91011 A4B910125 A4B910140 A4B91021 A4B910225 A4B910240	B IVDR	EUDAMED record Report an error
Respiratory syncytial virus (rsv)	W0105040605	Respiratory Syncytial Virus Antigen Rapid Test A46210120, A46210220	B IVDR	EUDAMED record Report an error
Saliva collection devices	W05019002	Saliva Collection System CS-S01	A IVDR	EUDAMED record Report an error
Shigella	W0105011714	Shigella Rapid Test SGL-f2398/79	– 98/79	EUDAMED record Report an error
Strep. pneumoniae - RT & POC	W0105090109	Mycoplasma Pneumoniae Antigen Rapid Test Device A46710120,A46710220	B IVDR	EUDAMED record Report an error
Syphilis reagents other	W0105010399	Syphilis FIA98/79	– 98/79	EUDAMED record Report an error
Zika virus	W0105040630	Zika IgG/IgM Rapid Test ZIKA-W23M98/79	– 98/79	EUDAMED record Report an error

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