Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3017107376

FEI Number

3017107376

Entity Name

Hongyu Biotech (ShenZhen) Co., Ltd.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

10A,Finance Center, No.22 Taizi Road, Nanshan District, Shenzhen Guangdong 518067, CN

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device,Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Hongyu Biotech (ShenZhen) Co., Ltd. (Owner Number: 10079513)

Owner / Operator Contact Address

10A,Finance Center, No.22 Taizi Road, Nanshan District, Shenzhen, CN-GD 518067, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Cast Cover Wound Closure Strip Medical compression sock PVA Bandages PVA Swabs PVA Sponges Nasal strips Shower Safety Seating Folding Walker Non-woven Tape; non-woven surgical tape; PE Tape; transparent surgical tape; I.V Dressing; Silicone Tape Surgical Tape; Foam Tape PVC; Elastic Bandages; Athletic Tape; Bandage Transparent Film Dressing, Alginate Dressings, Film Island Dressing, Non-woven Adhesive Wound Dressing with pad, Foam dressing, Super Absorbent Dressing, Hydrocolloid Dressing, Adhesive Island Dressing, Nasal Strips, Acne Patch, Hydrocolloid Gel Bandages Scar Gel silicone scar sheet Silicone Dressing Silicone Tape Hydrophilic wound dressing Silicone Gel Sheeting Silver Alginate Dressing Trap Door Dressing (NAD Dressing, wound, occlusive), Silicone Contact Layer, Petrolatum Gauze Dressing

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
KIA	Cover, Cast	General Hospital	Class 1	880.6185	2024-08-09
FPX	Strip, Adhesive, Closure, Skin	General Hospital	Class 1	880.5240	2024-12-23
FQL	Stocking, Medical Support (For General Medical Purposes)	General Hospital	Class 1	880.5780	2023-02-21
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2020-12-10
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2023-02-21
ILS	Adaptor, Hygiene	Physical Medicine	Class 1	890.5050	2023-02-21
ITJ	Walker, Mechanical	Physical Medicine	Class 1	890.3825	2023-02-21
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2020-12-10
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2020-12-10
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2020-12-10
FRO	Dressing, Wound, Drug	Unknown	Class U	N/A	2023-06-04
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2020-12-10

Official Correspondent

Shumiao Yang

US Agent Details

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

Related Public Records

Same Entity

Hongyu Biotech (ShenZhen) 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
K830425	Maddak, Inc.	TOILET SEAT RAISED	1983-05-09
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

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0003-06	B. Braun Medical, Inc.	U	D-Stat Dry Hemostatic Bandage. The product is an adhesive bandage.
Z-0038-2025	3M Company Health Care Business 3m Center	U	3M Tegaderm CHG, Chlorhexidine Gluconate I.V. Securement Dressing, REF 1658R
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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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017107376. Last updated year: 2026. Please use registration number 3017107376 when referencing this establishment in official correspondence.