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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 1 of 11

Device	Model / Reference	Registries	Class	Status
MyoCheck D-Dimer Quantitativer Schnelltest (Fluoreszenz Immunoassay)	BT2105-D-Dimer	EUDAMED	IVD General	Active
CrinoCheck FT3 Quantitativer Schnelltest (Fluoreszenz Immunoassay)	BT2214-FT3	EUDAMED	IVD General	Active
BodyCheck HbA1c Quantitativer Schnelltest (Fluoreszenz Immunoassay)	BT2501-HBA1C	EUDAMED	IVD General	Active
MyoCheck BNP Quantitativer Schnelltest (Fluoreszenz Immunoassay)	BT2109-BNP	EUDAMED	IVD General	Active
CrinoCheck E2 Quantitativer Schnelltest (Fluoreszenz Immunoassay)	BT2212-E2	EUDAMED	IVD General	Active
MyoCheck cTnI Quantitativer Schnelltest (Fluoreszenz Immunoassay)	BT2101-cTnl	EUDAMED	IVD General	Active
CrinoCheck TES Quantitativer Schnelltest (Fluoreszenz Immunoassay)	BT2211-TES	EUDAMED	IVD General	Active
CrinoCheck PRL Quantitativer Schnelltest (Fluoreszenz Immunoassay)	BT2207-PRL	EUDAMED	IVD General	Active
BodyCheck HCY Quantitativer Schnelltest (Fluoreszenz Immunoassay)	BT2221-HCY	EUDAMED	IVD General	Active
MyoCheck Myo Quantitativer Schnelltest (Fluoreszenz Immunoassay)	BT2102-Myo	EUDAMED	IVD General	Active
CrinoCheck AMH Quantitativer Schnelltest (Fluoreszenz Immunoassay)	CrinoCheck AMH Quantitativer Schnelltest (Fluoreszenz Immunoassay)	EUDAMED	IVD General	Active
CrinoCheck FT4 Quantitativer Schnelltest (Fluoreszenz Immunoassay)	BT2215-FT4	EUDAMED	IVD General	Active
BodyCheck HbA1c Quantitativer Schnelltest (Fluoreszenz Immunoassay)	BT2501-HBA1C	EUDAMED	IVD General	Active
PROG Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0503304	EUDAMED	IVD General	Active
TSH/TT3/TT4 Rapid Quantitative Test (Fluorescence Immunoassay)	HR0203301	EUDAMED	IVD General	Active
CEA Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0505703	EUDAMED	IVD General	Active
AMH Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0503704	EUDAMED	IVD General	Active
Total cholesterol test strip（Electrochemical Method）	BT06011	EUDAMED	IVD General	Active
D-Dimer Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0508002	EUDAMED	IVD General	Active
3, 4-Methylenedioxymetha mphetamine (MDMA) Rapid Test (Urine)	BT0104501	EUDAMED	IVD General	Active
TESTO Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0525003	EUDAMED	IVD General	Active
Cys-C Rapid Quantitative Test	BT2602	EUDAMED	IVD General	Active
BNP Rapid Quantitative Test	BT2109	EUDAMED	IVD General	Active
Digoxin Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0501103	EUDAMED	IVD General	Active
CA50 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0505802	EUDAMED	IVD General	Active
Malaria P.f/P.v Antigen Rapid Test	BT0102101	EUDAMED	IVD General	Active
IL-6 Rapid Quantitative Test	BT2306	EUDAMED	IVD General	Active
CK-MB Rapid Quantitative Test (Fluorescence Immunoassay)	HR0201801	EUDAMED	IVD General	Active
CEA/AFP Rapid Quantitative Test	BT2403	EUDAMED	IVD General	Active
Biotime	BT0504501	EUDAMED	IVD General	Active
HCY Rapid Quantitative Test	BT2221	EUDAMED	IVD General	Active
CA15-3 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0506001	EUDAMED	IVD General	Active
TSH Rapid Quantitative Test	BT2204	EUDAMED	IVD General	Active
TT4 Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0517002	EUDAMED	IVD General	Active
Ferritin Rapid Quantitative Test (Fluorescence Immunoassay)	HR0203101	EUDAMED	IVD General	Active
PG II Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0505403	EUDAMED	IVD General	Active
INS Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0504005	EUDAMED	IVD General	Active
PCR-CE β-Thalassemia Kit	04110021	EUDAMED	IVD General	Active
CA15-3 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0506002	EUDAMED	IVD General	Active
hs-cTnT Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0505003	EUDAMED	IVD General	Active
FT3 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0501803	EUDAMED	IVD General	Active
AFP Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0505605	EUDAMED	IVD General	Active
ASO Rapid Quantitative Test	BT0200901	EUDAMED	IVD General	Active
SAA Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0501304	EUDAMED	IVD General	Active
TG Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0502203	EUDAMED	IVD General	Active
HE4 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0506503	EUDAMED	IVD General	Active
PRL Rapid Quantitative Test	BT2207	EUDAMED	IVD General	Active
hs-CRP Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0501203	EUDAMED	IVD General	Active
BNP Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0500704	EUDAMED	IVD General	Active
Insulin Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0527002	EUDAMED	IVD General	Active

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Importers

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Notified Bodies

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