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Wuxi Nest Biotechnology Co., Ltd: FDA-registered device maker in Wuxi Jiangsu, China, 2 510(k) clearances

Name: Wuxi Nest Biotechnology Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Wuxi Nest Biotechnology Co., Ltd is registered with the FDA (registration 3009302820) in Wuxi Jiangsu, China. It lists 13 device types. The FDA files 2 510(k) clearances under its listings, the newest dated August 15, 2024. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3009302820
Address: No. 530, Xida Road, Meicun Industrial Park, Xinwu District, Wuxi Jiangsu, China, 214112
Owner or operator: WUXI NEST BIOTECHNOLOGY CO., LTD (10070331)
Roles: Contract manufacturer, Manufacturer
First device listed: April 16, 2020
Registered through: 2026
Brand names listed: Disposable Intranasal Atomization Device, Disposable Pen Injector Assembly, Disposable Sampler, Disposable Sampler Inactivated Transport Media, Disposable Sampler Viral Transport Media, Elisa plate, NES Sample Vial, Nasopharyngeal Specimen Collection Swab and more

Devices it lists

Device	Product code	Class	Role	Source
Applicator, Absorbent Tipped, Sterile	KXG	1	Manufacturer	accessdata.fda.gov
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	JQC	1	Manufacturer	accessdata.fda.gov
Container, Specimen, Sterile	FMH	1	Manufacturer	accessdata.fda.gov
Culture Media, Non-Propagating Transport	JSM	1	Contract manufacturer	accessdata.fda.gov
Culture Media, Non-Selective And Non-Differential	JSG	1	Manufacturer	accessdata.fda.gov
Flask, Tissue Culture	KJA	1	Manufacturer	accessdata.fda.gov
Instrument, Manual, Surgical, General Use	MDM	1	Manufacturer	accessdata.fda.gov
Microbial Nucleic Acid Storage And Stabilization Device	QBD	2	Contract manufacturer	accessdata.fda.gov
Multi-Target Respiratory Specimen Nucleic Acid Test Including Sars-Cov-2 And Other Microbial Agents	QOF	2	Contract manufacturer	accessdata.fda.gov
Nasal Spray, Ent Delivery	KCO	1	Manufacturer	accessdata.fda.gov
Real Time Nucleic Acid Amplification System	OOI	2	Contract manufacturer	accessdata.fda.gov
Syringe, Piston	FMF	2	Manufacturer	accessdata.fda.gov
Transport Medium, Notified Per The Vtm Guidance	QMC	1	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
August 15, 2024	K240961	Disposable Pen Injector Assembly	FMF	Substantially Equivalent	Wuxi Nest Biotechnology Co., Ltd.	accessdata.fda.gov
June 18, 2024	K240774	Pen Injector	FMF	Substantially Equivalent	Wuxi Nest Biotechnology Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated August 15, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.