Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3005083505

FEI Number

3005083505

Entity Name

ZHEJIANG HONGYU MEDICAL COMMODITY CO., LTD.

City/State/Country

YIWU Zhejiang, CN

Establishment Address

No.668,ChanHua Road,Industrial Functional Area,Fotang Town, YIWU Zhejiang 322002, 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),Manufacture Medical Device

Owner / Operator

ZHEJIANG HONGYU MEDICAL COMMODITY CO., LTD. (Owner Number: 9071821)

Owner / Operator Contact Address

No.668,ChanHua Road ,Industrial Functional Area,Fotang Town, YIWU, CN-ZJ 322002, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Triangular Bandage 30 pcs, 40 pcs, 50 pcs Hongyu First aid kit without drug instrument cases, first aid case 10788 baby healthcare kit tongue depressor PILL BOX band-aid Surgical Face Mask KN95 Face Mask Disposable Medical Face Mask Disposable Isolation PIMPLE PATCH / Acne and Spot Patches/Blister patches CMC Gelling Fiber Dressing Alginate Dressings; foam dressing, hydrogel dressing,I.V. dressing;Wound Dressing,Hydrocollid dressing tender grips Gauze Pad, Gauze Dressing Pads PVA lap sponges,PVA swab Cotton Ball NASAL DILATOR, DILATOR, NASAL Elastomer, Silicone, For Scar Management - Scar Gel,Silicone Dressing ,Silicone Tape Shoulder Cushion ABD Combine Pad, 5 x 9 PIMPLE PATCH / Acne and Spot Patches/Blister patches incise film Silicone Superabsorbent Dressing, Silicone Wound Contact Layer Hongyu SCISSORS Hongyu FORCEPS Instant Hot Pack Trauma Pad,Non-Adherent Pad, Non-Stick Pad,First Aid Blanket Digital Thermometer Alcohol Prep Pad/Cleansing Pads,BZK Antiseptic Swab Povidone Iodine Wipe Sting Relief Wipe Tourniquet Cotton Swabs, Non-Sterile BANDAGE, ELASTIC Non-Sterile Disposable Surgical Face Mask-Level 3 wellness patch; warm pad Safety Pin Hongyu Tape and bandage, adhesive corn plaster PLASTER liquid bandage cooling patch Instant Hot Pack Face Shield, Month-To-Mouth Mast, Mask

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
ILI	Sling, Arm	Physical Medicine	Class 1	890.3640	2006-11-22
LRR	First Aid Kit With Drug	Unknown	Class N	N/A	2020-03-25
OHO	First Aid Kit Without Drug	General, Plastic Surgery	Class 1	878.4014	2011-08-17
FMA	Depressor, Tongue, Non-Surgical	General Hospital	Class 1	880.6230	2023-02-08
NXB	Dispenser, Solid Medication	Physical Medicine	Class 1	890.5050	2026-04-17
PYO	Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use	General Hospital	Class 1	880.5240	2024-10-22
KHA	Mask, Scavenging	Anesthesiology	Class 1	868.5590	2020-03-25
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2020-07-31
NAC	Dressing, Wound, Hydrophilic	General, Plastic Surgery	Class 1	878.4018	2006-11-22
CBH	Device, Fixation, Tracheal Tube	Anesthesiology	Class 1	868.5770	2017-08-22
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2006-11-22
LWF	Dilator, Nasal	Ear, Nose, Throat	Class 1	874.3900	2015-09-15
MDA	Elastomer, Silicone, For Scar Management	General, Plastic Surgery	Class 1	878.4025	2015-08-22
IOY	Support, Arm	Physical Medicine	Class 1	890.3475	2025-11-28
FRL	Fiber, Medical, Absorbent	General Hospital	Class 1	880.5300	2024-06-20
NAD	Dressing, Wound, Occlusive	General, Plastic Surgery	Class 1	878.4020	2019-08-21
LRW	Scissors, General, Surgical	General, Plastic Surgery	Class 1	878.4800	2006-11-22
HTD	Forceps	General, Plastic Surgery	Class 1	878.4800	2006-11-22
IME	Pack, Hot Or Cold, Reusable	Physical Medicine	Class 1	890.5700	2008-08-11
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2006-11-22
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2025-06-12
LRJ	Disinfectant, Medical Devices	General Hospital	Class 1	880.6890	2006-11-22
GAX	Tourniquet, Nonpneumatic	General, Plastic Surgery	Class 1	878.5900	2024-01-25
KXF	Applicator, Absorbent Tipped, Non-Sterile	General Hospital	Class 1	880.6025	2006-11-22
FQM	Bandage, Elastic	General Hospital	Class 1	880.5075	2006-11-22
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-08-04
OMW	Adhesive Backed Thermal Skin Patches	Physical Medicine	Class 1	890.5710	2023-08-14
MDM	Instrument, Manual, Surgical, General Use	General, Plastic Surgery	Class 1	878.4800	2006-11-22
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2005-03-29
NEC	Bandage, Liquid, Skin Protectant	General Hospital	Class 1	880.5090	2017-02-22
IMD	Pack, Hot Or Cold, Disposable	Physical Medicine	Class 1	890.5710	2006-11-22
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2006-11-22

Official Correspondent

Zeng Juhong

US Agent Details

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

Related Public Records

Same Entity

ZHEJIANG HONGYU MEDICAL COMMODITY 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
K944481	Garan Scientific, Inc.	THE HEART PROTECTOR	1995-04-10
K881936	Iberhospitex, S.A.	OPER-FILM-ADHESIVE MEMBRANE	1988-08-31
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
K010462	Avita Corporation	AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES)	2001-04-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
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.
Z-0016-2019	COVIDIEN LLC	1	Kerlix Bandage Roll, 100 Cotton, 8 Ply, Large 4-1/2 x 9.3 (11.4 cm x 2.8 m), REF 6716 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.
Z-0017-2019	COVIDIEN LLC	1	Dermacea Gauze Fluff Roll, 6 Ply, 4-1/2 x 4-1/8 yd (11.4 cm x 3.7 m), REF 441103 Product Usage: Used as both primary and secondary dressing for bandaging heads, limbs and difficult-to-dress wounds.

Similar Registrations

Registration Number	Establishment Name	Location
3013530901	HANGZHOU ROLLMED CO.,LTD.	Hangzhou Zhejiang, CN
3007123908	APOTHECARIES SUNDRIES MFG PVT LTD	GURUGRAM Haryana, IN
3006633581	SUZHOU VICON INDUSTRIAL CO., LTD	SUZHOU Jiangsu, CN
3013002868	BRACE ALIGN	Soddy Daisy, TN, US
3010220099	RIVAL VIETNAM CO.,LTD	HUNG YEN PROVINCE, VN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3005083505. Last updated year: 2026. Please use registration number 3005083505 when referencing this establishment in official correspondence.