Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020978033

FEI Number

3020978033

Entity Name

DAWN BREEZE INT'L TRADING LIMITED

City/State/Country

Wan Chai Hong Kong, CN

Establishment Address

RM 02, 7/F, SPA Centre, No. 53-55 Lockhart Road, Wan Chai Hong Kong 999077, CN

Establishment Type(s)

Manufacture Medical Device,Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Dawn Breeze Int'l Trading Limited (Owner Number: 10082887)

Owner / Operator Contact Address

RM 02, 7/F, SPA Centre, No. 53-55 Lockhart Road, Wan Chai, CN-HK 999077, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Scissors First Aid Kit Elastic Ankle Support Elastic Wrist Support Alcohol Pads Adhesive Bandage, Non-woven Tape, Waterproof Tape Elastic Knee Support, Elastic Elbow Support Elastic Bandage, Self-Adherent Bandage, Gauze Rolls Eye Pad first aid kit with drug Folding Stretcher Burn Gel, Burn Dressing Mixed case of elastic supports (elastic wrist support, elastic elbow support, elastic calf support, elastic ankle support, elastic knee support) Cold Pack, Hot Pack

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2022-06-01
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2021-10-11
ITW	Joint, Ankle, External Brace	Physical Medicine	Class 1	890.3475	2021-10-11
ILH	Splint, Hand, And Components	Physical Medicine	Class 1	890.3475	2021-10-11
LKB	Pad, Alcohol, Device Disinfectant	Unknown	Class U	N/A	2021-10-11
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2021-10-11
ITQ	Joint, Knee, External Brace	Physical Medicine	Class 1	890.3475	2021-10-11
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2021-10-11
HMP	Pad, Eye	General, Plastic Surgery	Class 1	878.4440	2021-10-11
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2021-11-25
FPP	Stretcher, Hand-Carried	General Hospital	Class 1	880.6900	2022-03-23
NAE	Dressing, Wound, Hydrogel Without Drug And/Or Biologic	General, Plastic Surgery	Class 1	878.4022	2021-10-11
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2021-10-11
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2021-10-11

Official Correspondent

Zhongming Gao

US Agent Details

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

Related Public Records

Same Entity

Dawn Breeze Int'l Trading Limited

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
K843874	Beiersdorf, Inc.	LEUKOPOR SURGICAL TAPE	1985-02-21
K915446	Sun Glitz Corp.	STRETCH WRAP	1992-05-06
K833120	Acme United Corp.	ONE TIME COMPOUND BENZOIN TINCTURE-	1983-12-29
K870091	Avery Intl.	IV SECUREMENT DEVICE USING PCCE THERMO. FILM	1987-02-04
K880871	John Wagner Associates, Inc.	GRABBER WARM PACK/MINI MINI HEATER/FOOT HEATER	1988-05-20

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

Similar Registrations

Registration Number	Establishment Name	Location
8010298	RUDOLF MEDICAL GMBH + CO. KG	FRIDINGEN Baden-Wurttemberg, DE
8043496	REDA INSTRUMENTE GMBH	TUTTLINGEN Baden-Wurttemberg, DE
8040373	NADEEM SURGICAL CORP. PRIVATE LTD.	SIALKOT Punjab, PK
2531475	URAMIX, INC.	E Lansdowne, PA, US
1417592	MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020978033. Last updated year: 2026. Please use registration number 3020978033 when referencing this establishment in official correspondence.