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Xiamen BioRay Biotechnology Co., Ltd.

China·CN-MF-000045502

Last updated June 8, 2026

Information

Country: China
Address: Room 101, Room 201, Room 301, No.1, Pingcheng Middle Road, Haicang District, 361026 Xiamen City, Fujian Province, PEOPLE’S REPUBLIC OF CHINA, Xiamen, China
Website: biotime.cn
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86-15059327317
PRRC Contact: Huabin Xu
EUDAMED SRN: CN-MF-000045502
FDA FEI Number: —
DUNS Number: —

Catalogue (423)

Page 9 of 9

Device	Model / Reference	Registries	Class	Status
SARS-CoV-2 Antigen Rapid Test	BT0200201	EUDAMED	IVD General	Active
AFP Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0505603	EUDAMED	IVD General	Active
PCT Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0501402	EUDAMED	IVD General	Active
Biotime	BT0101501	EUDAMED	IVD General	Active
HbA1c Rapid Quantitative Test	BT2501	EUDAMED	IVD General	Active
Mycoplasma Pneumoniae Antigen Rapid Qualitative Test	BT0102601	EUDAMED	IVD General	Active
Methamphetamine （MET） Rapid Test（Urine）	BT0104701	EUDAMED	IVD General	Active
Total IgE Rapid Quantitative Test (Fluorescence Immunoassay)	BT2901	EUDAMED	IVD General	Active
Lp-PLA2 Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0500805	EUDAMED	IVD General	Active
FT3 Rapid Quantitative Test	BT2214	EUDAMED	IVD General	Active
E2 Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0526003	EUDAMED	IVD General	Active
Biotime	BT0500104	EUDAMED	IVD General	Active
E2 Rapid Quantitative Test	BT2212	EUDAMED	IVD General	Active
MAU Rapid Quantitative Test	BT2601	EUDAMED	IVD General	Active
hs-CRP Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0501202	EUDAMED	IVD General	Active
Pregnancy loss detection Kit	04110011	EUDAMED	IVD General	Active
LH Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0523002	EUDAMED	IVD General	Active
Ferritin Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0503003	EUDAMED	IVD General	Active
Biotime	BT0500404	EUDAMED	IVD General	Active
PCR-CE NOTCH2NLC Kit	04110017	EUDAMED	IVD General	Active
CA19-9 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0506103	EUDAMED	IVD General	Active
PG I Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0505301	EUDAMED	IVD General	Active
PROG Rapid Quantitative Test (Fluorescence Immunoassay)	HR0200901	EUDAMED	IVD General	Active

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Importers

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Notified Bodies

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Authorities

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