Manufacturer

Zybio

ChinaLegal entities : Zybio Inc.

Markets : Austria · Germany · Italy · Netherlands · Northern Ireland · Türkiye · United States

Approvals : EU – class A, B, C · United States (FDA) – · class I

EU representative : Lotus NL B.V. (Netherlands)

PMS@zy-ivd.com

36 categories, 100 models including 100 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
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Cbc-reagents (cleaning-/diluting-/lysing-/sheath-fluids)	W0103010105	01.09.31.02.Z3.052 refs H3 Check3 refs H58 DN H58 DR2 refs H58 LD2 refs 9 others H58 LN2 refs H58 LS2 refs LA3 refs Lyse2 refs Probe Cleanser Protein Cleaning Solution Z5 DN Z5 LB3 refs Z5 LD	A, B IVDR	EUDAMED record Report an error
Automated urine analysers	W020101020103	U160098/79 U160198/79 U160298/79 U260098/79 U260198/79 7 others U260298/79 U261098/79 U261198/79 U261298/79 U360098/79 U360198/79 U360298/79	– 98/79	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	EXM30002 refs EXM6000, EXM62002 refs EXP 160, EXP 161, EXP 1623 refs EXP 160R, EXP 161R2 refs Quantitative Real-time PCR System EXP 960, EXP 961, EXP 962, EXP 9633 refs 1 other ZIP-96V	A IVDR	EUDAMED record Report an error
Various sample processing instruments - other	W02069099	FD-A, FR-A, FDR-A, FD-T FD-B, FR-B, FDR-B, FDR-B, FR-B3 refs FFPE-B, FFPE-T3 refs Nucleic Acid Extraction Kit (Magnetic Bead Method) 01.09.20.02.BP.083 refs S-B, S-T3 refs Universal Nucleic Acid Extraction Kit (Magnetic Bead Method)3 refs 1 other WB-B, WB-T3 refs	A IVDR	EUDAMED record Report an error
Automated whole blood hematology analysers - low routine (throughput <= 100 samples/hr)	W0202010101	EXZ 6000, EXZ 6010, EXZ 60203 refs EXZ 6000Pro, EXZ 6010Pro, EXZ 6020Pro3 refs Hematology Analyzer EXZ 8000 EXZ 8000, EXZ 8010, EXZ 80203 refs Hematology Analyzer EXZ 8000Pro EXZ 8000Pro, EXZ 8010Pro, EXZ 8020Pro3 refs Hematology Analyzer Z50, Z522 refs	B IVDR	EUDAMED record Report an error
Buffers (haemostasis)	W0103020903	Diluent3 refs TH-PClean3 refs TH-PDesorb2 refs TH-SP-Diluent2 refs	A IVDR	EUDAMED record Report an error
Control plasma for haemostasis	W0103020702	Anti-Xa Controls3 refs Coagulation Controls2 refs D-Dimer Controls2 refs Fibrin/fibrinogen Degradation Products (FDP) Controls2 refs	C IVDR	EUDAMED record Report an error
Mass - spectrometry system	W020303	EX-Accuspec EXS 2000, EXS 2600, EXS 3000, EXS 36002 refs EXS200098/79 EXS260098/79	C IVDR, 98/79	EUDAMED record Report an error
Automated coagulometers	W0202020102	EXT 3800, EXT 3810, EXT 38203 refs EXT 4800, EXT 4810, EXT 48203 refs EXT 9800, EXT 9810, EXT 98203 refs	A IVDR	EUDAMED record Report an error
Automated immunochemistry analysers - moderate routine (throughput > 100 and <= 250 test/h)	W0201020102	EXI 1800, EXI 1810, EXI 1820, EXI 18303 refs EXI 2400, EXI 24202 refs Q8 Pro	A IVDR	EUDAMED record Report an error
D-dimer	W0103020503	D-Dimer (D-D) Kit(Latex Enhanced Immunoturbidimetric Method)2 refs98/79 D-Dimer Assay (CLIA)98/79 D-Dimer Reagent Kit (Immunoturbidimetric Method)3 refs	C IVDR, 98/79	EUDAMED record Report an error
Multilevel blood controls	W0103010503	CHECK-BFI3 refs CHECK-XR3 refs H5 Check3 refs	B IVDR	EUDAMED record Report an error
Reagents for (automated) haematology analyzer - other	W0103010199	H58 FD3 refs H58 FN3 refs H58 FR3 refs	A IVDR	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	Cell-free DNA Extraction Kit (Magnetic Bead Method)3 refs Nucleic Acid Extraction Kit (Magnetic Bead Method) 01.09.20.00.B2.083 refs Nucleic Acid Extraction Kit (Magnetic Bead Method) 01.09.20.08.B2.083 refs	A IVDR	EUDAMED record Report an error
Automated 3 part hematology analysers	W0202010201	Hematology Analyzer Z3 CRP Z3 CRP, Z30 CRP, Z31 CRP3 refs Hematology Analyzer Z3, Z30, Z313 refs	B IVDR	EUDAMED record Report an error
Chemistry analysers - low routine (random access without ise mode test/h <= 400)	W0201010101	EXC200,EXC2202 refs EXC400, EXC4202 refs	A IVDR	EUDAMED record Report an error
Fibrinogen assays (factor i)	W0103020201	Fibrinogen (FIB) Kit (Immunoturbidimetric Method)98/79 Fibrinogen Reagent Kit (Clotting Method)3 refs	C IVDR, 98/79	EUDAMED record Report an error
Haematology reagents - other	W01030199	H56 LD-I H56 LD-II	A IVDR	EUDAMED record Report an error
Interleukin 6 (il-6)	W01030609	IL-6 Assay (CLIA)98/79 Interleukin-6 Assay (Immunofluorescence)98/79	– 98/79	EUDAMED record Report an error
Activated partial thromboplastin time	W0103020102	Activated Partial Thromboplastin Time Reagent Kit (Clotting Method)3 refs	C IVDR	EUDAMED record Report an error
Antithrombin	W0103020602	Antithrombin Ⅲ Reagent Kit (Chromogenic Substrate Method)3 refs	C IVDR	EUDAMED record Report an error
Automated blood culture analysers	W02030201	EXB 120, EXB 120S, EXB 120P, EXB60-Lite, EXB60-Vita, EXB60-Nova3 refs	A IVDR	EUDAMED record Report an error
Chemistry analysers - moderate routine (random access without ise mode test/h > 400 and <= 800)	W0201010102	EXC460, EXC4702 refs	A IVDR	EUDAMED record Report an error
Cytokines calibrators/controls	W01030608	Interleukin-6 Control2 refs	C IVDR	EUDAMED record Report an error
Fibrinogen degradation products	W0103020502	Fibrin/fibrinogen Degradation Products (FDP) Reagent Kit (Immunoturbidimetric Method)3 refs	C IVDR	EUDAMED record Report an error
Haemostasis controls - other	W0103020799	D-Dimer Control2 refs	C IVDR	EUDAMED record Report an error
Immunochemistry readers	W0201020201	Fluorescence Immunochromatography Analyzer EXR 100, EXR 110, EXR 1203 refs	A IVDR	EUDAMED record Report an error
IVD general use consumable devices - other	W0599	LP3 refs	A IVDR	EUDAMED record Report an error
Nucleic acid testing instruments except micro-arrays - other	W02050199	EXM 3000 Duo	A IVDR	EUDAMED record Report an error
Prothrombin time ( quick test )	W0103020101	Prothrombin Time Reagent Kit (Clotting Method)3 refs	C IVDR	EUDAMED record Report an error
Respiratory tract infections - multiplex NA reagents	W0105070503	Molaccu Mycoplasma pneumoniae and Chlamydia pneumoniae Nucleic Acid Detection Kit (Real-time PCR)3 refs	C IVDR	EUDAMED record Report an error
Reticulocyte controls	W0103010506	CHECK-XN3 refs	B IVDR	EUDAMED record Report an error
Semi-automated urine analysers	W020101020102	Urine Analyzer EXU 300, EXU 5002 refs	A IVDR	EUDAMED record Report an error
Standard heparin	W0103020303	Anti-Xa Reagent Kit (Chromogenic Substrate Method)3 refs	C IVDR	EUDAMED record Report an error
Thrombin time / reptilase / batroxobin time	W0103020103	Thrombin Time Reagent Kit (Clotting Method)3 refs	C IVDR	EUDAMED record Report an error
Whole blood calibrators	W0103010507	CAL2 refs	B IVDR	EUDAMED record Report an error

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