Data / Medical devices / China / Bestreat Safety & First Aid Solution Co., Ltd

Bestreat Safety & First Aid Solution Co., Ltd: FDA-registered device maker in Wuhan Hubei, China, 3 510(k) clearances

Name: Bestreat Safety & First Aid Solution Co., Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Bestreat Safety & First Aid Solution Co., Ltd is registered with the FDA (registration 3025413691) in Wuhan Hubei, China. It lists 35 device types. The FDA files 3 510(k) clearances under its listings, the newest dated September 1, 2023. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3025413691
Address: Room 401, 4th Floor, Building 2, Bonded Zone, No.378 Gexin Avenue, Dongxihu District, Wuhan Hubei, China, 430040
Owner or operator: Bestreat Safety & First Aid Solution Co., Ltd (10086417)
Roles: Exporter to the US, Manufacturer
First device listed: November 8, 2022
Registered through: 2027
Brand names listed: 77 pcs First Aist Kit, 42 Pieces First Aid Kit, Absorbent Cotton Dressing, Adhesive Bandage, Adhesive Tape, Wound Closure Tape, Anesthesia mask, Antiseptic Hand Sanitizer, Bandages, Burn Dressing, Chest Seal and more

Devices it lists

Device	Product code	Class	Role	Source
Anaerobic Box Glove	JTM	1	Manufacturer	accessdata.fda.gov
Applicator, Absorbent Tipped, Non-Sterile	KXF	1	Manufacturer	accessdata.fda.gov
Bandage, Elastic	FQM	1	Manufacturer	accessdata.fda.gov
Bedding, Disposable, Medical	KME	1	Manufacturer	accessdata.fda.gov
Disinfectant, Medical Devices	LRJ	1	Manufacturer	accessdata.fda.gov
Dispenser, Solid Medication	NXB	1	Manufacturer	accessdata.fda.gov
Dressing, Compression	MHW	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Hydrogel Without Drug And/Or Biologic	NAE	1	Manufacturer	accessdata.fda.gov
Dressing, Wound, Occlusive	NAD	1	Manufacturer	accessdata.fda.gov
Elastomer, Silicone, For Scar Management	MDA	1	Manufacturer	accessdata.fda.gov
Fiber, Medical, Absorbent	FRL	1	Manufacturer	accessdata.fda.gov
Finger Cot	LZB	1	Manufacturer	accessdata.fda.gov
First Aid Kit With Drug	LRR	N	Manufacturer	accessdata.fda.gov
First Aid Kit Without Drug	OHO	1	Manufacturer	accessdata.fda.gov
Forceps	HTD	1	Manufacturer	accessdata.fda.gov
Gauze / Sponge,Nonresorbable For External Use	NAB	1	Manufacturer	accessdata.fda.gov
Gauze/Sponge, Internal, X-Ray Detectable	GDY	1	Manufacturer	accessdata.fda.gov
Hemostatic Wound Dressing Without Thrombin Or Other Biologics	QSY	U	Manufacturer	accessdata.fda.gov
Joint, Knee, External Brace	ITQ	1	Manufacturer	accessdata.fda.gov
Mask, Gas, Anesthetic	BSJ	1	Exporter to the US	accessdata.fda.gov
Mask, Scavenging	KHA	1	Manufacturer	accessdata.fda.gov
Multiple Use Blood Lancet For Single Patient Use Only	QRL	2	Exporter to the US	accessdata.fda.gov
Non-Surgical Gown	OEA	1	Manufacturer	accessdata.fda.gov
Pack, Hot Or Cold, Disposable	IMD	1	Manufacturer	accessdata.fda.gov
Pad, Eye	HMP	1	Manufacturer	accessdata.fda.gov
Scissors, Medical, Disposable	JOK	1	Manufacturer	accessdata.fda.gov
Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	QRK	2	Exporter to the US	accessdata.fda.gov
Sling, Arm	ILI	1	Manufacturer	accessdata.fda.gov
Solution, Isotonic	JCE	1	Manufacturer	accessdata.fda.gov
Splint, Hand, And Components	ILH	1	Manufacturer	accessdata.fda.gov
Stethoscope, Manual	LDE	1	Manufacturer	accessdata.fda.gov
Tape And Bandage, Adhesive	KGX	1	Manufacturer	accessdata.fda.gov
Tourniquet, Nonpneumatic	GAX	1	Manufacturer	accessdata.fda.gov
Valve, Non-Rebreathing	CBP	2	Exporter to the US	accessdata.fda.gov
Wound Dressing Kit	MCY	2	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
September 1, 2023	K213413	Hemostatic Dressing	QSY	Substantially Equivalent	Jiangsu Newvalue Medical Products Co., Ltd.	accessdata.fda.gov
January 25, 2023	K223314	Disposable Blood Lancets	QRK	Substantially Equivalent	Huaian Hening Medical Instruments Co., Ltd.	accessdata.fda.gov
November 17, 2017	K171961	Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)	CBP	Substantially Equivalent	Xiamen Compower Medical Tech. Co., Ltd.	accessdata.fda.gov

Compare with other makers

Updated September 1, 2023. 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.