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Bioteke Corporation (Wuxi) Co., Ltd.

China·CN-MF-000007517

Last updated May 27, 2026

What Bioteke Corporation (Wuxi) Co., Ltd. makes

Bioteke Corporation produces in vitro diagnostic (IVD) devices for clinical and self-testing applications, including general specimen collection kits for laboratory use, nucleic acid extraction and isolation kits, and dedicated instruments for sample preparation. Their portfolio also includes rapid immunochromatographic test kits for SARS-CoV-2 antigen detection, saliva-based pregnancy tests, and hormone assays like follicle-stimulating hormone (FSH) tests, alongside consumables for nucleic acid processing.

The company’s devices are classified under IVD General, Class A, Class C, and Class I categories, with regulatory listings in the EU’s EUDAMED database, the FDA’s 510(k) and UDI registries. The manufacturer operates from Wuxi, China.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: China
Address: No. 90, Huiming Road, Huishan, Wuxi City, Jiangsu, 214000, China, Wuxi, China
Website: www.bioteke.cn
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86 （0510）8332 3992
PRRC Contact: Guoqiang Zhang
EUDAMED SRN: CN-MF-000007517
FDA FEI Number: —
DUNS Number: 560011452

Catalogue (98)

Page 2 of 2

Device	Model / Reference	Registries	Class	Status
Nucleic Acid Extraction Kit	AU17012	EUDAMED	Class A	Active
Nucleic Acid Extraction Kit	DP4611	EUDAMED	Class A	Active
Disposable Virus Sampling Swab Kits	ST8001-0	EUDAMED	Class A	Active
Pipette	PT50	EUDAMED	Class A	Active
Disposable Virus Sampling Swab Kits	ST9001-1	EUDAMED	Class A	Active
Reaction sample well	BTK-8-B4-20-00	EUDAMED	Class A	Active
BioTeke	ST8001-1	FDA UDI	Class I	Active
BioTeke	ST7001-1	FDA UDI	Class I	Active
BioTeke	ST7001-1	FDA UDI	Class I	Active
BioTeke	ST8001-2	FDA UDI	Class I	Active
BioTeke	AU17011	FDA UDI	Class I	Active
BioTeke	ST9001-1	FDA UDI	Class I	Active
BioTeke	AU17012	FDA UDI	Class I	Active
BioTeke	ST7001-2	FDA UDI	Class I	Active
BioTeke	ST9001-2	FDA UDI	Class I	Active
BioTeke	ST8001-2	FDA UDI	Class I	Active
BioTeke	AU1001S	EUDAMEDFDA UDI	Class I	Active
BioTeke	AU17011	FDA UDI	Class I	Active
BioTeke	ST7001-2	FDA UDI	Class I	Active
BioTeke	BTK-H2201	FDA UDI	N	Active
BioTeke	ST7001-1	FDA UDI	Class I	Active
BioTeke	AU17011	FDA UDI	Class I	Active
BioTeke	AU1001	EUDAMEDFDA UDI	Class I	Active
BioTeke	AU1001-96	EUDAMEDFDA UDI	Class I	Active
BioTeke	BTK-H2205	FDA UDI	N	Active
BioTeke	ST8001-1	FDA UDI	Class I	Active
BioTeke	ST7001-1	FDA UDI	Class I	Active
BioTeke	ST9001-2	FDA UDI	Class I	Active
BioTeke	BTK-H2202	FDA UDI	N	Active
BioTeke	ST9001-1	FDA UDI	Class I	Active
BioTeke	AU17012	FDA UDI	Class I	Active
bioteke	ST9001-2	FDA UDI	Class I	Active
BioTeke	ST7001-2	FDA UDI	Class I	Active
Disposable Sterile Sampling Swab	SS001-5	EUDAMEDFDA UDI	Class I	Active
Disposable Sterile Sampling Swab	SS001-1	EUDAMEDFDA UDI	Class I	Active
Disposable Virus Sampling Swab Kits	ZK1500-2	EUDAMED	Class A	Active
Disposable Sterile Sampling Swab	SS001-7	EUDAMEDFDA UDI	Class I	Active
BioTeke Sterile Disposable Virus Sampling Kit	K211707	FDA 510(k)	Class I	Active
Disposable Sterile Sampling Swab	SS001-6	EUDAMEDFDA UDI	Class I	Active
Disposable Sterile Sampling Swab	SS001-3	EUDAMEDFDA UDI	Class I	Active
Disposable Virus Sampling Swab Kits	ST7001-2	EUDAMEDFDA UDI	Class A	Active
Fully Automatic Nucleic Acid Extraction and Detection Integrated Machine	BTK-16	EUDAMED	Class A	Active
Disposable sampling swab	ST001-2	EUDAMED	Class I	Active
Sample Preservation Solution	ST7001-3	EUDAMED	Class A	Active
Disposable Sterile Sampling Swab	SS001-2	EUDAMEDFDA UDI	Class I	Active
Disposable Sterile Sampling Swab	SS001-4	EUDAMEDFDA UDI	Class I	Active
Disposable sampling swab	ST001-5	EUDAMED	Class I	Active
Disposable sampling swab	ST001-1, ST001-2, ST001-3，ST001-4, ST001-5	EUDAMED	Class I	Active
Multiple Respiratory Multipathogen Antigen Test Kit (Immunochromatographic Assay)	ICA2114-7	EUDAMED	Class C	Active

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