Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025413691

FEI Number

3025413691

Entity Name

BESTREAT SAFETY & FIRST AID SOLUTION CO., LTD

City/State/Country

Wuhan Hubei, CN

Establishment Address

Room 401, 4th Floor, Building 2, Bonded Zone, No.378 Gexin Avenue, Dongxihu District, Wuhan Hubei 430040, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Bestreat Safety & First Aid Solution Co., Ltd (Owner Number: 10086417)

Owner / Operator Contact Address

Room 401, 4th Floor, Building 2, Bonded Zone, No.378 Gexin Avenue, Dongxihu District, Wuhan, CN-HB 430040, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Stethoscope Splint Trade/Device Name: CPR Mask with Oxygen Port, CPR Mask without Oxygen Port, Infant CPR Mask without Oxygen Port, Non-Rebreathing Valve (15mmOD), Non-Rebreathing Valve (18.5mm) Kaolin gauze Trauma Pad Forceps Burn Dressing Instant Cold Pack Disposable Blood Lancets Pill Box Silicone tape Adhesive Bandage Adhesive Tape Dressing kits Disoposable Gloves Absorbent Cotton Dressing Chest Seal Finger Cot Eye Wash First Aid Dressing Bandage Hemostatic Dressing Scissors Foil Blanket Face Mask X-ray Detectable Absorbent Dressing Bandages Antiseptic Hand Sanitizer Isolation Gown Disposable Tourniquet Cotton Tips

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LDE	Stethoscope, Manual	Cardiovascular	Class 1	870.1875	2022-11-08
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2022-11-08
CBP	Valve, Non-Rebreathing	Anesthesiology	Class 2	868.5870	2025-09-07
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2022-11-08
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2022-11-08
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2022-11-08
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2022-11-08
QRL	Multiple Use Blood Lancet For Single Patient Use Only	General, Plastic Surgery	Class 2	878.4850	2026-06-01
QRK	Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature	General, Plastic Surgery	Class 2	878.4850	2026-06-01
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2023-11-10
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2024-04-30
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2022-11-08
MCY	Wound Dressing Kit	General Hospital	Class 2	880.5075	2025-03-28
JTM	Anaerobic Box Glove	Microbiology	Class 1	866.2120	2025-06-13
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2022-11-08
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2022-11-08
LZB	Finger Cot	General Hospital	Class 1	880.6250	2022-11-08
JCE	Solution, Isotonic	Pathology	Class 1	864.4010	2025-04-08
MHW	Dressing, Compression	General Hospital	Class 1	880.5075	2022-11-08
QSY	Hemostatic Wound Dressing Without Thrombin Or Other Biologics	Unknown	Class U	N/A	2025-12-15
JOK	Scissors, Medical, Disposable	General Hospital	Class 1	880.6820	2022-11-08
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2022-11-08
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2025-06-13
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2022-11-08
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2022-11-08
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2025-04-08
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2024-11-26
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2022-11-08
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2022-11-08

Official Correspondent

Taylor Yang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Bestreat Safety & First Aid Solution Co., Ltd

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K945177	Eagle Health Supplies	4-O2 JR. (CPR MOUTH BARRIER)	1994-11-01
K852723	The Huxley Instrument Corp.	FOERSTER SPONGE FORCEPS, SERRATED, 7+SS 410 OR 420	1985-07-15
K873512	Arthropedics, Inc.	SERRATED GRASPING FORCEPS, RIGHT	1987-11-02
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20
K944481	Garan Scientific, Inc.	THE HEART PROTECTOR	1995-04-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0505-2022	Philips North America Llc	1	Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Z-0506-2022	Philips North America Llc	1	Infant Heel Warmers w/strap, Reference # 989805603201 1223
Z-0013-2019	COVIDIEN LLC	1	Kerlix AMD Antimicrobial Bandage Roll, 6 Ply, 4-1/2 x 12.3 (11.4 cm x 3.7m), REF 3332 Product Usage- as both primary and secondary dressing containing PHMB (polyhexamethylene biguanide) to resist bacterial colonization within the dressing and bacterial penetration through the dressing.
Z-0014-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100% Cotton, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m), REF 6715 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0015-2019	COVIDIEN LLC	1	Kerlix Gauze Roll, 6 Ply, Large 4-1/2 x 4-1/8 yd (11.4 cm x 3.7m) Stretched, REF 7880 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

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3042481106	SMART HEALTH LLC	Owings Mills, MD, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025413691. Last updated year: 2026. Please use registration number 3025413691 when referencing this establishment in official correspondence.