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SHENZHEN DAKEWE BIO-ENGINEERING CO., LTD.

China·CN-MF-000002174

Last updated September 17, 2026

Information

Country: China
Address: Room 702-703, Building No.1 Shenzhen Biomedicine Innovations Industrial Park, No.14 Jinhui Road, Kengzi Street, Pingshan District, Shenzhen, China
Website: www.dakewe.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +86-755-86235300
PRRC Contact: Wei Jiang
EUDAMED SRN: CN-MF-000002174
FDA FEI Number: 3017170972
DUNS Number: —

Catalogue (42)

Device	Model / Reference	Registries	Class	Status
Dakewe	ITMO	FDA UDI	Class II	Active
BioSci™	VM	FDA UDI	Class I	Active
Dakewe	ITMM	FDA UDI	Class II	Active
Biosci™	MSB	FDA UDI	Class I	Active
Biosci™	MSY	FDA UDI	Class I	Active
Disposable Sampling Swab	3982811	EUDAMED	Class I	Active
Biosci™ Inactivated Transport Medium, Biosci™ ITM	K220059	FDA 510(k)	Class II	Active
BioSci™ Disposable Virus Sampling Tubes	K230035	FDA 510(k)	Class I	Active
OmniTrans Transport System	K240235	FDA 510(k)	Class I	Active
Disposable Sampling Swab	3982841	EUDAMED	Class I	Active
Eosin Staining Solution	4960221	EUDAMEDFDA UDI	Class A	Active
Antigen Retrieval Solution	4980211	EUDAMED	Class A	Active
Disposable Sampling Swab	3982842	EUDAMED	Class I	Active
Eosin Staining Solution	4960211	EUDAMED	Class A	Active
Giemsa Staining Solution	4960511	EUDAMED	Class A	Active
Disposable Virus Sampling Tube	3980222	EUDAMED	Class A	Active
Immunochromogenic Reagent	4980722	EUDAMED	Class A	Active
Cytokeratin Pan Antibody Reagent	4910892	EUDAMED	IVD General	Active
Wash Solution	4980421	EUDAMED	Class A	Active
Giemsa Staining Solution	4960512	EUDAMED	Class A	Active
Disposable Swab	3980822	EUDAMED	Class I	Active
CK20 Antibody Reagent	4910372	EUDAMED	IVD General	Active
Wash Solution	4980411	EUDAMED	Class A	Active
Disposable Swab	3980812	EUDAMED	Class I	Active
Hematoxylin-Eosin Staining Solution	4960331	EUDAMED	Class A	Active
Nucleic Acid Extraction Reagent	8934011	EUDAMED	Class A	Active
Papanicolaou Staining Solution	4960411	EUDAMED	Class A	Active
Cytokeratin Pan Antibody Reagent	4910893	EUDAMED	IVD General	Active
Mounting Medium	4080131	EUDAMED	Class A	Active
Disposable Virus Sampling Tube	3980232	EUDAMED	Class A	Active
Disposable Virus Sampling Tube	3980122	EUDAMED	Class A	Active
SMA Antibody Reagent	4910364	EUDAMED	IVD General	Active
Hematoxylin Staining Solution	4960111	EUDAMEDFDA UDI	Class A	Active
Dewax Solution	4980511	EUDAMED	Class A	Active
Transport Medium	3981011	EUDAMED	Class A	Active
Probe Cleaning Solution	4081211	EUDAMED	Class A	Active
Disposable Sampling Swab	3982871	EUDAMED	Class I	Active
Disposable Virus Sampling Tube	3980132	EUDAMED	Class A	Active
Ki-67 Antibody Reagent	4910103	EUDAMED	IVD General	Active
p63 Antibody Reagent	4910074	EUDAMED	IVD General	Active
Immunochromogenic Reagent	4980721	EUDAMED	Class A	Active
Disposable Sampling Swab	3982812	EUDAMED	Class I	Active

Related Companies

Authorised Representatives

SUNGO Europe B.V. NL

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

Shenzhen Dakewe Bio-engineering Co., Ltd US