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HOB Biotech Group Corp., Ltd.

China·CN-MF-000023974

Last updated September 18, 2026

Information

Country: China
Address: No. 9, Dongyanli Road,Suzhou Industrial Park, Suzhou,Jiangsu, China
Website: www.hob-biotech.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86 0512 69561966
PRRC Contact: Tina Tian
EUDAMED SRN: CN-MF-000023974
FDA FEI Number: —
DUNS Number: —

Catalogue (263)

Page 5 of 6

Device	Model / Reference	Registries	Class	Status
BioCLIA Autoimmune Control Set, Cardiolipin Screen	MY00327	EUDAMED	IVD General	Active
BioCLIA Autoimmune Calibrator Set, β2 Glycoprotein 1 IgA	MY00226	EUDAMED	IVD General	Active
BioCLIA Autoimmune Control Set, CCP	MY00336	EUDAMED	IVD General	Active
BioCLIA Allergy Reagent Kit, E5	MY01285	EUDAMED	IVD General	Active
BioCLIA Allergy Reagent Kit, F84	MY01205	EUDAMED	IVD General	Active
BioCLIA Allergy Reagent Kit, F27	MY01294	EUDAMED	IVD General	Active
BioCLIA Allergy Reagent Kit, F24	MY01293	EUDAMED	IVD General	Active
BioCLIA Autoimmune Reagent Kit, Scl-70	MY00103C	EUDAMED	IVD General	Active
BioCLIA Allergy Specific IgE Conjugate and Microparticle Set	MY01314	EUDAMED	IVD General	Active
BioCLIA Autoimmune Reagent Kit, Ro60	MY00098C	EUDAMED	IVD General	Active
BioCLIA Autoimmune Reagent Kit, RF IgG	MY00180	EUDAMED	IVD General	Active
BioCLIA Autoimmune Reagent Kit, CCP	MY00132C	EUDAMED	IVD General	Active
BioCLIA Autoimmune Control Set, gp210	MY00318	EUDAMED	IVD General	Active
BioCLIA Autoimmune Control Set, sp100	MY00319	EUDAMED	IVD General	Active
BioCLIA Autoimmune Reagent Kit, ENA Screen I	MY00147C	EUDAMED	IVD General	Active
BioCLIA Autoimmune Reagent Kit, PLA2R	MY01710C	EUDAMED	IVD General	Active
Line Immuno Assay (LIA) for the Detection of Antibodies in Autoimmune Vasculitis	MB00178	EUDAMED	IVD General	Active
BioCLIA Autoimmune Control Set, SLA/LP	MY00323	EUDAMED	IVD General	Active
BioCLIA Allergy Reagent Kit, F4	MY01288	EUDAMED	IVD General	Active
BioCLIA Autoimmune Control Set, ENA Screen I	MY00351	EUDAMED	IVD General	Active
BioCLIA Autoimmune Reagent Kit, LC-1	MY00117C	EUDAMED	IVD General	Active
BioCLIA Autoimmune Reagent Kit, β2 Glycoprotein 1 IgM	MY02215C	EUDAMED	Class B	Active
BioCLIA Autoimmune Calibrator Set, sp100	MY00217	EUDAMED	IVD General	Active
BioCLIA Allergy Reagent Kit, I3	MY01698	EUDAMED	IVD General	Active
BioCLIA Autoimmune Calibrator Set, PR3	MY00214	EUDAMED	IVD General	Active
BioCLIA Autoimmune Control Set, DGP IgG	MY00345	EUDAMED	IVD General	Active
BioCLIA Autoimmune Reagent Kit, Ro52	MY00155	EUDAMED	IVD General	Active
BioCLIA Autoimmune Reagent Kit, dsDNA	MY00148	EUDAMED	IVD General	Active
BioCLIA Autoimmune Control Set, MPO	MY00315	EUDAMED	IVD General	Active
BioCLIA Autoimmune Reagent Kit, Cardiolipin IgM	MY02199C	EUDAMED	Class B	Active
BioCLIA Allergy Reagent Kit, F75	MY01700	EUDAMED	IVD General	Active
BioCLIA Autoimmune Reagent Kit, SS-B/La	MY00150	EUDAMED	IVD General	Active
BioCLIA Autoimmune Control Set, RF IgM	MY00334	EUDAMED	IVD General	Active
BioCLIA Autoimmune Calibrator Set, GBM	MY00215	EUDAMED	IVD General	Active
BioCLIA Allergy Reagent Kit, G8	MY01191	EUDAMED	IVD General	Active
BioCLIA Autoimmune Control Set, GAD	MY00346	EUDAMED	IVD General	Active
Line Immuno Assay (LIA) for the Detection of Antinuclear Antibodies	MB00175	EUDAMED	IVD General	Active
BioCLIA Autoimmune Calibrator Set, LC-1	MY00219	EUDAMED	IVD General	Active
BioCLIA Allergy Reagent Kit, T12	MY01299	EUDAMED	IVD General	Active
BioCLIA Autoimmune Reagent Kit, sp100	MY00115C	EUDAMED	IVD General	Active
BioCLIA Autoimmune Reagent Kit, AMA-M2	MY00118C	EUDAMED	IVD General	Active
BioCLIA Allergy Reagent Kit, F23	MY01292	EUDAMED	IVD General	Active
BioCLIA Allergy Reagent Kit, D202	MY01212	EUDAMED	IVD General	Active
BioCLIA Autoimmune Reagent Kit, sp100	MY00166	EUDAMED	IVD General	Active
BioCLIA Autoimmune Reagent Kit, PR3	MY00163	EUDAMED	IVD General	Active
BioCLIA Autoimmune Reagent Kit, RF IgG	MY00129C	EUDAMED	IVD General	Active
BioCLIA Allergy Reagent Kit, F423	MY01214	EUDAMED	IVD General	Active
BioCLIA Allergy Reagent Kit, Sx1	MY01306	EUDAMED	IVD General	Active
BioCLIA Autoimmune Reagent Kit, Histone	MY00159	EUDAMED	IVD General	Active
BioCLIA Autoimmune Calibrator Set, Ribosomal P	MY00207	EUDAMED	IVD General	Active

Related Companies

Authorised Representatives

Emergo Europe B.V. NL

Importers

Not available yet.

Notified Bodies

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Authorities

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