Manufacturer

Hybribio

ChinaLegal entities : Chaozhou Hybribio Biochemistry Ltd., Guangzhou Hybribio Medicine Technology Ltd., Hybribio Medtech Device Co.,Ltd

Markets : Germany · Netherlands · Spain

Approvals : EU – class A

EU representative : Emergo Europe B.V. (Netherlands)

12 categories, 54 models including 54 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
Full genotyping high-risk + low-risk HPV - NA reagents	W0105041004	16 Tests/Kit98/79 20-HPV Genotype(A) ：16 Tests98/79 20-HPV Genotype(A) ：48 Tests98/79 20-HPV Genotype(A) ：96 Tests98/79 20-HPV Genotype(B) ：16 Tests98/79 11 others 20-HPV Genotype(B) ：48 Tests98/79 20-HPV Genotype(B) ：96 Tests98/79 30 Tests/Kit98/79 32 Tests/Kit98/79 37 HPV GenoArray Diagnostic Kit 30 Tests/Kit98/79 40-HPV Genotype(A+B) ：16 Tests98/79 40-HPV Genotype(A+B) ：48 Tests98/79 40-HPV Genotype(A+B) ：96 Tests98/79 6 Tests/Kit2 refs98/79 60 Tests/Kit98/79 90 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Reagents for DNA and/or RNA extraction and preparation: bacteria and/or virus	W0105900101	1 mL/tube, 24 tubes/box; 1 mL/tube, 48 tubes/box; 1 mL/tube, 96tubes/box; 2 mL/tube, 47tubes/box; 2 mL/tube, 48tubes/box; 2 mL/tube, 96 tubes/box; 3 mL/tube, 48 tubes/box; 3 mL/tube, 96 tubes/box 16 Tests/ Kit, 32 Tests/ Kit, 48 Tests/ Kit, 128 Tests/ Kit, 160 Tests/ Kit, 192 Tests/ Kit3 refs 16 Tests/ Kit, 48 Tests/ Kit 16 Tests/Kit, 32 Tests/Kit, 48 Tests/Kit, 128Tests/Kit, 160 Tests/Kit, 192 Tests/Kit3 refs 30 Tests/ Kit, 24 Tests/ Kit, 6 Tests/ Kit 4 others 48 Tests/Kit 50 tests/kit 6 Tests/Kit，30 Tests/Ki HBMP-R/96: 16 Tests/ Kit, 96 Tests/ Kit, 192 Tests/ Kit; HBMP-NO-R-A9600-T1: 16 Tests/ Kit, 192 Tests/ Kit; HBMP-NO-R-A9601: 16 Tests/ Kit, 192 Tests/ Kit3 refs	A IVDR	EUDAMED record Report an error
Nucleic acid testing integrated extraction /amplification /detection systems	W02050116	Fully Automated Nucleic Acid Extraction and Real-time PCR System HB-IEX96Q HB-IEX96A HB-IEX96S HBNP-4801A HBNP-4803A 3 others HBNP-9601A HBNP-ME32A HBQW-3200A	A IVDR	EUDAMED record Report an error
Nucleic acid hybridization units	W02050101	HB-2012A HBHM-3001S HBHM-9000A HHM-3	A IVDR	EUDAMED record Report an error
STIS / STDS (c.trachomatis, n.gonorrhoeae ,m.genitalium, t.vaginalis, ureaplasma spp….) combination - multiplex NA reagents	W0105070501	16 Tests/Kit98/79 48 Tests/Kit3 refs98/79 6 Tests/Kit98/79 96 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Other HPV - NA reagents	W0105041005	24 Tests/ Kit98/79 48 Tests/ Kit2 refs98/79 6 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Automated systems for the management of pre and post-analysis	W02060101	HBLH-9600A HBLH-Mini96A	A IVDR	EUDAMED record Report an error
Partial genotyping high-risk HPV - NA reagents	W0105041003	48 Tests/Kit98/79 6 Tests/Kit98/79	– 98/79	EUDAMED record Report an error
Samples collection devices - other	W05019099	HBPM/D: 3mL/bottle 25 bottles/box,3mL/bottle 96 bottles/box; HBPM/T: 10mL/bottle 25bottles/box,20mL/bottle 25bottles/box2 refs NT-2, NT-3, NT-4, NT-5, NT-6, NT-73 refs	A IVDR	EUDAMED record Report an error
Strep. b detection by NA reagents	W0105011104	48 tests/kit98/79 6 tests/kit98/79	– 98/79	EUDAMED record Report an error
Automated sample transport systems	W02060102	HBPS-9600A	A IVDR	EUDAMED record Report an error
Urine collection devices - other	W05010299	1.5 mL/Tube, 25 tubes/box; 3.0 mL/Tube, 25 tubes/box; 0.8 mL/Tube, 48 tubes/box	A IVDR	EUDAMED record Report an error

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