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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 (509)

Page 2 of 11

Device	Model / Reference	Registries	Class	Status
Biotime	/	EUDAMED	IVD General	Active
TG Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0502205	EUDAMED	IVD General	Active
INS Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0504002	EUDAMED	IVD General	Active
BNP Rapid Quantitative Test (Fluorescence Immunoassay)	HR0201301	EUDAMED	IVD General	Active
PCT Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0501001	EUDAMED	IVD General	Active
SAA Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0511001	EUDAMED	IVD General	Active
G17 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0505202	EUDAMED	IVD General	Active
TPOAb Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0502403	EUDAMED	IVD General	Active
C-peptide Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0504105	EUDAMED	IVD General	Active
TES Rapid Quantitative Test	BT2211	EUDAMED	IVD General	Active
Biotime	BT0101401	EUDAMED	IVD General	Active
HbA1c Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0530002	EUDAMED	IVD General	Active
Malaria P.f Antigen Rapid Test	BT0101901	EUDAMED	IVD General	Active
PRL Rapid Quantitative Test (Fluorescence Immunoassay)	HR0202701	EUDAMED	IVD General	Active
TT3 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0501901	EUDAMED	IVD General	Active
CA19-9 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0506105	EUDAMED	IVD General	Active
PCR-CE NOTCH2NLC Kit	04110016	EUDAMED	IVD General	Active
hscTnI Rapid Quantitative Test	BT0201201	EUDAMED	IVD General	Active
hs-cTnT Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0500502	EUDAMED	IVD General	Active
E2 Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0526002	EUDAMED	IVD General	Active
h-FABP Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0500903	EUDAMED	IVD General	Active
Biotime	BT0000401	EUDAMED	Class A	Active
β-HCG Rapid Quantitative Test	BT2202	EUDAMED	IVD General	Active
CEA Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0531001	EUDAMED	IVD General	Active
FSH Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0503002	EUDAMED	IVD General	Active
TT4 Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0517003	EUDAMED	IVD General	Active
AMH Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0503705	EUDAMED	IVD General	Active
Pregnancy loss detection Kit	04110012	EUDAMED	IVD General	Active
Total IgE Rapid Quantitative Test (Fluorescence Immunoassay)	HR0203201	EUDAMED	IVD General	Active
AFP Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0505601	EUDAMED	IVD General	Active
NT-proBNP Rapid Quantitative Test (Fluorescence Immunoassay)	HR0200601	EUDAMED	IVD General	Active
h-FABP Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0500905	EUDAMED	IVD General	Active
TSH Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0501704	EUDAMED	IVD General	Active
TPOAb Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0532001	EUDAMED	IVD General	Active
CA72-4 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0506205	EUDAMED	IVD General	Active
FSH Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0503001	EUDAMED	IVD General	Active
FSH Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0503004	EUDAMED	IVD General	Active
IL-6 Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0520001	EUDAMED	IVD General	Active
C-peptide Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0528002	EUDAMED	IVD General	Active
TT3 Rapid Quantitative Test (Fluorescence Immunoassay)	HR0201101	EUDAMED	IVD General	Active
D-Dimer Rapid Quantitative Test	BT2105	EUDAMED	IVD General	Active
HBP Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0501605	EUDAMED	IVD General	Active
FT3 Rapid Quantitative Test (Chemiluminescence Immunoassay)	W0102160999	EUDAMED	IVD General	Active
Biotime	BT0500403	EUDAMED	IVD General	Active
FSH Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0503003	EUDAMED	IVD General	Active
Tetrahydrocannabinol (THC) Rapid Test (Urine)	BT0104401	EUDAMED	IVD General	Active
Rapid aneuploidy detection Kit	04110010	EUDAMED	IVD General	Active
AFP Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0504001	EUDAMED	IVD General	Active
C-peptide Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0504101	EUDAMED	IVD General	Active
LH Rapid Quantitative Test (Fluorescence Immunoassay)	HR0202601	EUDAMED	IVD General	Active

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Importers

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Notified Bodies

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Authorities

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