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Shenzhen Zijian Biotechnology

ChineEntités : Shenzhen Zijian Biotechnology Co., Ltd

Marchés : Allemagne · Espagne · Pays-Bas

Autorisations : UE – classe A

Mandataire UE : Lotus NL B.V. (Pays-Bas)

Site web sales@szzijian.com

41 catégories, 170 modèles dont 170 en vente, 1 pays

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93/42 Ancienne directive, pas encore certifié selon le règlement MDR
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Catégorie	Code EMDN	Modèles enregistrés	Classe	Contact
Samples transport, bottles	W05020103	Activated type:25pcs/kit V 20-10-2598/79 Disposable Virus Sampling Tube Activated type:100pcs/kit V 10-3.5-10098/79 Disposable Virus Sampling Tube Activated type:100pcs/kit V 15-6-10098/79 Disposable Virus Sampling Tube Activated type:100pcs/kit V 2-1-10098/79 Disposable Virus Sampling Tube Activated type:100pcs/kit V 5-3.5-10098/79 71 autres Disposable Virus Sampling Tube Activated type:200pcs/kit V 2-1-20098/79 Disposable Virus Sampling Tube Activated type:25pcs/kit V 10-3.5-2598/79 Disposable Virus Sampling Tube Activated type:25pcs/kit V 15-6-2598/79 Disposable Virus Sampling Tube Activated type:25pcs/kit V 30-12-2598/79 Disposable Virus Sampling Tube Activated type:25pcs/kit V 5-3.5-2598/79 Disposable Virus Sampling Tube Activated type:25pcs/kit V 50-10-2598/79 Disposable Virus Sampling Tube Activated type:25pcs/kit V 50-15-2598/79 Disposable Virus Sampling Tube Activated type:50pcs/kit V 5-2-5098/79 Disposable Virus Sampling Tube Activated type:50pcs/kit V 10-3.5-5098/79 Disposable Virus Sampling Tube Activated type:50pcs/kit V 15-6-5098/79 Disposable Virus Sampling Tube Activated type:50pcs/kit V 20-10-5098/79 Disposable Virus Sampling Tube Activated type:50pcs/kit V 30-12-5098/79 Disposable Virus Sampling Tube Activated type:50pcs/kit V 5-2.5-5098/79 Disposable Virus Sampling Tube Activated type:50pcs/kit V 5-3.5-5098/79 Disposable Virus Sampling Tube Inactivated type I:100pcs/kit VI 10-3.5-10098/79 Disposable Virus Sampling Tube Inactivated type I:100pcs/kit VI 15-6-10098/79 Disposable Virus Sampling Tube Inactivated type I:100pcs/kit VI 2-1-10098/79 Disposable Virus Sampling Tube Inactivated type I:100pcs/kit VI 5-3.5-10098/79 Disposable Virus Sampling Tube Inactivated type I:200pcs/kit VI 2-1-20098/79 Disposable Virus Sampling Tube Inactivated type I:25pcs/kit VI 10-3.5-2598/79 Disposable Virus Sampling Tube Inactivated type I:25pcs/kit VI 15-6-2598/79 Disposable Virus Sampling Tube Inactivated type I:25pcs/kit VI 20-10-2598/79 Disposable Virus Sampling Tube Inactivated type I:25pcs/kit VI 30-12-2598/79 Disposable Virus Sampling Tube Inactivated type I:25pcs/kit VI 5-3.5-2598/79 Disposable Virus Sampling Tube Inactivated type I:25pcs/kit VI 50-10-2598/79 Disposable Virus Sampling Tube Inactivated type I:25pcs/kit VI 50-15-2598/79 Disposable Virus Sampling Tube Inactivated type I:50pcs/kit VI 10-3.5-5098/79 Disposable Virus Sampling Tube Inactivated type I:50pcs/kit VI 15-6-5098/79 Disposable Virus Sampling Tube Inactivated type I:50pcs/kit VI 20-10-5098/79 Disposable Virus Sampling Tube Inactivated type I:50pcs/kit VI 30-12-5098/79 Disposable Virus Sampling Tube Inactivated type I:50pcs/kit VI 5-2-5098/79 Disposable Virus Sampling Tube Inactivated type I:50pcs/kit VI 5-2.5-5098/79 Disposable Virus Sampling Tube Inactivated type I:50pcs/kit VI 5-3.5-5098/79 Disposable Virus Sampling Tube Inactivated type II:100pcs/kit VII 10-3.5-10098/79 Disposable Virus Sampling Tube Inactivated type II:100pcs/kit VII 15-6-10098/79 Disposable Virus Sampling Tube Inactivated type II:100pcs/kit VII 2-1-10098/79 Disposable Virus Sampling Tube Inactivated type II:100pcs/kit VII 5-3.5-10098/79 Disposable Virus Sampling Tube Inactivated type II:200pcs/kit VII 2-1-20098/79 Disposable Virus Sampling Tube Inactivated type II:25pcs/kit VII 10-3.5-2598/79 Disposable Virus Sampling Tube Inactivated type II:25pcs/kit VII 15-6-2598/79 Disposable Virus Sampling Tube Inactivated type II:25pcs/kit VII 20-10-2598/79 Disposable Virus Sampling Tube Inactivated type II:25pcs/kit VII 30-12-2598/79 Disposable Virus Sampling Tube Inactivated type II:25pcs/kit VII 5-3.5-2598/79 Disposable Virus Sampling Tube Inactivated type II:25pcs/kit VII 50-10-2598/79 Disposable Virus Sampling Tube Inactivated type II:25pcs/kit VII 50-15-2598/79 Disposable Virus Sampling Tube Inactivated type II:50pcs/kit VII 10-3.5-5098/79 Disposable Virus Sampling Tube Inactivated type II:50pcs/kit VII 15-6-5098/79 Disposable Virus Sampling Tube Inactivated type II:50pcs/kit VII 20-10-5098/79 Disposable Virus Sampling Tube Inactivated type II:50pcs/kit VII 30-12-5098/79 Disposable Virus Sampling Tube Inactivated type II:50pcs/kit VII 5-2-5098/79 Disposable Virus Sampling Tube Inactivated type II:50pcs/kit VII 5-2.5-5098/79 Disposable Virus Sampling Tube Inactivated type II:50pcs/kit VII 5-3.5-5098/79 Disposable Virus Sampling Tube Inactivated type III: 100pcs/kit VIII 2-1-10098/79 Disposable Virus Sampling Tube Inactivated type III:100pcs/kit VIII 15-6-10098/79 Disposable Virus Sampling Tube Inactivated type III:100pcs/kit VIII 10-3.5-10098/79 Disposable Virus Sampling Tube Inactivated type III:100pcs/kit VIII 5-3.5-10098/79 Disposable Virus Sampling Tube Inactivated type III:200pcs/kit VIII 2-1-20098/79 Disposable Virus Sampling Tube Inactivated type III:25pcs/kit VIII 10-3.5-2598/79 Disposable Virus Sampling Tube Inactivated type III:25pcs/kit VIII 15-6-2598/79 Disposable Virus Sampling Tube Inactivated type III:25pcs/kit VIII 20-10-2598/79 Disposable Virus Sampling Tube Inactivated type III:25pcs/kit VIII 30-12-2598/79 Disposable Virus Sampling Tube Inactivated type III:25pcs/kit VIII 5-3.5-2598/79 Disposable Virus Sampling Tube Inactivated type III:25pcs/kit VIII 50-10-2598/79 Disposable Virus Sampling Tube Inactivated type III:25pcs/kit VIII 50-15-2598/79 Disposable Virus Sampling Tube Inactivated type III:50pcs/kit VIII 10-3.5-5098/79 Disposable Virus Sampling Tube Inactivated type III:50pcs/kit VIII 15-6-5098/79 Disposable Virus Sampling Tube Inactivated type III:50pcs/kit VIII 20-10-5098/79 Disposable Virus Sampling Tube Inactivated type III:50pcs/kit VIII 30-12-5098/79 Disposable Virus Sampling Tube Inactivated type III:50pcs/kit VIII 5-2-5098/79 Disposable Virus Sampling Tube Inactivated type III:50pcs/kit VIII 5-2.5-5098/79 Disposable Virus Sampling Tube Inactivated type III:50pcs/kit VIII 5-3.5-5098/79	– 98/79	Fiche EUDAMED Signaler une erreur
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Nucleic Acid Extraction or Purification Kit Bulk Type A: 48 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Bulk Type B: 48 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type A: 20 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type A: 32 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type A: 36 reactions/ kit98/79 11 autres Nucleic Acid Extraction or Purification Kit Type A: 40 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type A: 48 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type A: 64 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type A: 96 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 20 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 32 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 36 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 40 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 48 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 64 reactions/ kit98/79 Nucleic Acid Extraction or Purification Kit Type B: 96 reactions/ kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Virology - RT & POC - other	W0105099099	SARS-CoV-2 (COVID-19) Antigen Rapid Detection Kit(Fluorescence Immunoassay) 100 Tests/kit98/79 SARS-CoV-2 (COVID-19) Antigen Rapid Detection Kit(Fluorescence Immunoassay) 25 Tests/kit98/79 SARS-CoV-2 (COVID-19) Antigen Rapid Detection Kit(Fluorescence Immunoassay) 50 Tests/kit98/79 SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold) 100 Tests/kit98/79 SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold) 25 Tests/kit98/79 8 autres SARS-CoV-2 Neutralizing Antibody Detection Kit (Colloidal Gold) 50 Tests/kit98/79 SARS-CoV-2 Neutralizing Antibody Detection Kit (Fluorescence Immunoassay) 25 Tests/kit98/79 SARS-CoV-2(COVID-19)Antibody Rapid Detection Kit(Lateral Flow Method) 100 Tests/kit98/79 SARS-CoV-2(COVID-19)Antibody Rapid Detection Kit(Lateral Flow Method) 25 Tests/kit98/79 SARS-CoV-2(COVID-19)Antibody Rapid Detection Kit(Lateral Flow Method) 50 Tests/kit98/79 SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit(Lateral Flow Method) 100 Tests/kit98/79 SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit(Lateral Flow Method) 25 Tests/kit98/79 SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit(Lateral Flow Method) 50 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Dengue - RT & POC	W0105099007	Dengue IgG/IgM FIA Kit 25 Tests/kit98/79 Dengue NS1 Ag FIA Kit 25 Tests/kit98/79 Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method) 100 Tests/kit98/79 Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method) 25 Tests/kit98/79 Dengue NS1 Antigen Rapid Test Kit(Lateral Flow Method) 50 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Influenza a and /or b - RT & POC	W0105099004	Flu A & Flu B Antigen Rapid Detection Kit (Lateral Flow Method) 100 Tests/kit98/79 Flu A & Flu B Antigen Rapid Detection Kit (Lateral Flow Method) 25 Tests/kit98/79 Flu A & Flu B Antigen Rapid Detection Kit (Lateral Flow Method) 50 Tests/kit98/79 Influenza A/B Virus Antigen Detection Kit(Fluorescence Immunoassay) 25 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Viral antigen/antibody detection - other	W0105040699	Monkeypox Virus Antigen Rapid Test(Lateral Flow Method) 25 Tests/kit98/79 SARS-CoV-2(COVID-19)Antigen Rapid Detection Kit(Lateral Flow Method) 1 Tests/kit98/79 SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method) 1 Test/kit98/79 SARS-CoV-2（COVID-19）Antigen Rapid Detection Kit (Lateral Flow Method) 5 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Virology - NA reagents - other	W0105040599	2019-nCoV Nucleic acid Detection Kit (Real Time PCR) 48 Tests/kit98/79 Monkeypox Virus Detection Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Mutation of SARS-CoV-2 nucleic acid Detection Kit (Real Time PCR) 48 Tests/kit98/79 Novel Coronavirus(SARS-CoV-2) Nucleic Acid Detection Kit (Isothermal Amplification) 48 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Enterovirus - NA reagents	W0105040502	Coxsackie virus group A type 16 (CA16) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Enterovirus type 71 (EV71) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Enterovirus Universal Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Multiple viruses - other	W01050799	Influenza A+B virus & 2019-nCoV (2019-nCoV orf1ab/N Gene) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Respiratory Pathogens Multiplex Nucleic Acid Diagnostic Kit (Multiplex PCR-Fluorescence Probing) 48 Tests/kit98/79 Rhinovirus, Respiratory Syncytial Virus & respiratory Adenovirus Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Plasmodium (malaria) - RT & POC	W0105090401	Malaria Pf/Pv Antigen Rapid Test Kit(Lateral Flow Method) 100 Tests/kit98/79 Malaria Pf/Pv Antigen Rapid Test Kit(Lateral Flow Method) 25 Tests/kit98/79 Malaria Pf/Pv Antigen Rapid Test Kit(Lateral Flow Method) 50 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Retroviruses - RT & POC - other	W0105090399	Zika NS1 Antigen Rapid Test Kit(Lateral Flow Method) 100 Tests/kit98/79 Zika NS1 Antigen Rapid Test Kit(Lateral Flow Method) 25 Tests/kit98/79 Zika NS1 Antigen Rapid Test Kit(Lateral Flow Method) 50 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Adenovirus - NA reagents	W0105040501	Adenovirus IgM Detection Kit(CLIA) 50 Tests/kit98/79 Mycoplasma Pheumonia IgM (MP IgM) Detection Kit(CLIA) 50 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
H. pylori antibody assays	W0105010402	H. Pylori Ab FIA Kit 25 Tests/kit98/79 Helicobacter Pylori IgG (HP IgG) Detection Kit(CLIA) 50 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Influenza & para influenza - NA reagents	W0105040504	Influenza A (H1N1) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Influenza A+B virus Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Multiple viruses - multiplex assays - other	W0105070399	Coxsackie virus group A type 16 & enterovirus type 71 Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79 Flu AB + SARS-CoV-2 Antigen Rapid Detection Kit(Colloidal Gold) 25 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	Automatic Nucleic Acid Extractor NEX-3298/79 Automatic Nucleic Acid Extractor NEX-9698/79	– 98/79	Fiche EUDAMED Signaler une erreur
Partial genotyping high-risk HPV - NA reagents	W0105041003	15 High-risk HPV DNA Diagnostic Kit(type16,18,31,33,35,39,45,51,52,53,56,58,59,66,68) (PCR-Fluorescence Probing) 48 Tests/kit98/79 HPV (Type 16 and 18) DNA Fluorescence Diagnostic Kit(PCR-Fluorescence Probing) 48 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Adenovirus	W0105040601	Adenovirus FIA Kit 25 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Automated immunochemistry analysers - low routine (throughput <= 100 test/h)	W0201020101	Fluorescence Immunoassay Analyzer FIS-10002 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	Multifunctional blood analyzer HEA-5000S3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Chemistry analysers - low routine (random access without ise mode test/h <= 400)	W0201010101	BAS-102 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Coagulation inhibitors - other	W0103020699	Thrombomodulin(TM) Detection Kit(CLIA) 50 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
D-dimer	W0103020503	D-Dimer Detection Kit(CLIA) 50 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
D-dimer - RT & POC	W0103020803	D-dimer Detection Kit(Fluorescence Immunoassay) 25 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Fibrinogen degradation products	W0103020502	Fibrin/Fibrinogen Degradation Products(FDP) Detection Kit(CLIA) 50 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Gram+ - gram- - fungi - multiplex NA reagents	W0105070201	Ureaplasma urealyticum (UU) and Neisseria Gonorrhoeae (NG) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
H. pylori antigen detection	W0105010401	H. Pylori Ag FIA Kit 25 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Influenza & para influenza / respiratory syncytial virus (rsv) / sars-cov - multiplex NA reagents	W0105070304	Flu A Flu B+RSV+ ADV Rapid Detection Kit(Colloidal Gold) 25 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Interleukin 6 (il-6)	W01030609	Interleukin 6 (IL-6) Detection Kit(CLIA) 50 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Mycobacterial detection by NA reagents	W0105010703	Mycobacterium Tuberculosis DNA Fluorescence Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Norovirus - NA reagents	W0105040516	Norovirus type GI/GII Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Optical laboratory microscopes	W0202050303	ZJ-B-2003 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Plasmin	W0103020504	α2-plasmininhibitor-Plasmin Complex(PIC) Detection Kit(CLIA) 50 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Plasminogen activator-inhibitors	W0103020506	Tissue plasminogen activator-Plasminogen activator inhibitor Complex(t-PAIC) Detection Kit(CLIA) 50 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Reagents for (automated) haematology analyzer - other	W0103010199	Testing pack 1 Tests/Kit3 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Respiratory syncytial virus (rsv) - NA reagents	W0105040505	Respiratory Syncytial Virus IgM (RSV-IgM) Detection Kit(CLIA) 50 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Rotavirus - NA reagents	W0105040506	Rotavirus (group A/B/C) Diagnostic Kit (PCR-Fluorescence Probing) 48 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Rsv - RT & POC	W0105099002	RSV FIA Kit 25 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Salmonella antibody assays	W0105011002	Salmonella IgM FIA Kit 25 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur
Stain solutions (histology/cytology)	W01030708	50 Tests/box6 réf.	A IVDR	Fiche EUDAMED Signaler une erreur
Thrombin-antithrombin III-complex	W0103020307	Thrombin-Antithrombin Complex(TAT) Detection Kit(CLIA) 50 Tests/kit98/79	– 98/79	Fiche EUDAMED Signaler une erreur

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