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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 (471)

Page 5 of 10

Device	Model / Reference	Registries	Class	Status
TT3 Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0515001	EUDAMED	IVD General	Active
SAA Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0511003	EUDAMED	IVD General	Active
TT3 Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0515002	EUDAMED	IVD General	Active
FSH Rapid Quantitative Test	BT2205	EUDAMED	IVD General	Active
25(OH)-D Rapid Quantitative Test	BT2801	EUDAMED	IVD General	Active
TESTO Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0503405	EUDAMED	IVD General	Active
β-HCG Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0502002	EUDAMED	IVD General	Active
Biotime	BT0500204	EUDAMED	IVD General	Active
Biotime	BT0504504	EUDAMED	IVD General	Active
BNP Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0506003	EUDAMED	IVD General	Active
MPV Rapid Quantitative Test (eRDA)	BT0300401	EUDAMED	IVD General	Active
FSH Rapid Quantitative Test (Fluorescence Immunoassay)	HR0202501	EUDAMED	IVD General	Active
hs-cTnI Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0518001	EUDAMED	IVD General	Active
HLC-100 Automatic Glycosylated Hemoglobin Analyzer	BT0000601	EUDAMED	Class A	Active
Biotime	BT0101601	EUDAMED	IVD General	Active
TSH Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0512002	EUDAMED	IVD General	Active
β-HCG Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0503605	EUDAMED	IVD General	Active
FT3 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0501804	EUDAMED	IVD General	Active
PCT Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0501003	EUDAMED	IVD General	Active
Amphetamine （AMP） Rapid Test（Urine）	BT0104601	EUDAMED	IVD General	Active
HbA1c Assay Kit (HPLC)	BT07002	EUDAMED	IVD General	Active
hs-cTnI Rapid Quantitative Test(Chemiluminescence Immunoassay)	BT0500601	EUDAMED	IVD General	Active
CA50 Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0505804	EUDAMED	IVD General	Active
Blood Ketone Test Strip（Electrochemical Method）	BT06009	EUDAMED	IVD General	Active
BNP Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0500703	EUDAMED	IVD General	Active
LH Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0503103	EUDAMED	IVD General	Active
IL-6 Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0520003	EUDAMED	IVD General	Active
D-Dimer Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0508003	EUDAMED	IVD General	Active
Tg Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0534002	EUDAMED	IVD General	Active
FT3 Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0514003	EUDAMED	IVD General	Active
Biotime	BT0500301	EUDAMED	IVD General	Active
CRP Rapid Quantitative Test (Fluorescence Immunoassay)	HR0202401	EUDAMED	IVD General	Active
Malaria P.f/Pan Antigen Rapid Test	BT0102201	EUDAMED	IVD General	Active
S100-β Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0504302	EUDAMED	IVD General	Active
Biotime	BT0101001	EUDAMED	IVD General	Active
CEA Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0505704	EUDAMED	IVD General	Active
Urinalysis Reagent Strips	BT0802003	EUDAMED	IVD General	Active
SAA Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0511002	EUDAMED	IVD General	Active
TT4 Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0517001	EUDAMED	IVD General	Active
S100-β Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0504304	EUDAMED	IVD General	Active
PCR-CE SMN1/2 Kit	04110003	EUDAMED	IVD General	Active
BGM-202 Blood Glucose Monitoring System	BT0000701	EUDAMED	Class A	Active
Biotime	BT0500203	EUDAMED	IVD General	Active
SCC Rapid Quantitative Test (Chemiluminescence Immunoassay)	BT0506405	EUDAMED	IVD General	Active
PCT Rapid Quantitative Test (Chemiluminescence Immunoassay)	HR0501002	EUDAMED	IVD General	Active
cTnI Rapid Quantitative Test (Fluorescence Immunoassay)	HR0200401	EUDAMED	IVD General	Active
Kawasaki IP-10 ELISA Kit	04110013	EUDAMED	IVD General	Active
PGI/ PGII Rapid Quantitative Test	BT21003	EUDAMED	IVD General	Active
PCR-CE FMR1 Kit	04110001	EUDAMED	IVD General	Active
Biotime	BT0504505	EUDAMED	IVD General	Active

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Importers

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Notified Bodies

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Authorities

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