Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008489813

FEI Number

3008489813

Entity Name

WEIHAI HONGYU NONWOVEN FABRIC PRODUCTS CO., LTD

City/State/Country

Weihai Shandong, CN

Establishment Address

No.567, Gushan Road, Area of Economy and Technique, Weihai Shandong 264207, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Weihai Hongyu Nonwoven Fabric Products Co., Ltd (Owner Number: 10033229)

Owner / Operator Contact Address

No.567, Gushan Road, Area of Economy and Technique, Weihai, CN-SD 264207, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Kidney Tray Adhesive Level 4 Surgical Gowns Umbilical Clamp Nasal Aspirator Scalpel Basin Bedcover Gauze Checking Pad Sponge Sterile Towl Gauze 4*4-12P 7.5% lodine 10% lodine face shield CSR Wrap Level 3 surgical gowns Non-surgical isolation gown Disposable Medical Protective Clothing Syringe 10ml General syringe Syringe 3ml Syringe 20ml Head Rest Cover Surgical Masks Bowl:Kidney Tray Isolation Shoe Covers Medical Masker Diaper Nitrile Examination Gloves leg Sets Hand Towel 05579 Sleeve Hand Towel 14.625*27 Towel Clip Surgical Wrap Surgical Drape Sterilization wraps Surgical Cap Medical Mask N95 Bed Bag Pillowcase Bedsheet Disposable Adult Diapers; adult brief Scalpel 11# Ray Gauze 10*10cm 16P Hemostat

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
LRP	Tray, Surgical	General, Plastic Surgery	Class 1	878.4800	2015-01-30
KGX	Tape And Bandage, Adhesive	General Hospital	Class 1	880.5240	2015-01-30
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2022-04-13
HFW	Clamp, Umbilical	Obstetrics/Gynecology	Class 2	884.4530	2015-01-30
GCY	Apparatus, Suction, Single Patient Use, Portable, Nonpowered	General, Plastic Surgery	Class 1	878.4680	2015-01-30
GDX	Scalpel, One-Piece	General, Plastic Surgery	Class 1	878.4800	2010-07-22
FNY	Basin, Emesis	General Hospital	Class 1	880.6730	2010-07-22
FMW	Cover, Mattress (Medical Purposes)	General Hospital	Class 1	880.6190	2010-07-22
NAB	Gauze / Sponge,Nonresorbable For External Use	General, Plastic Surgery	Class 1	878.4014	2010-07-22
IAL	Iodine (Tincture)	Pathology	Class 1	864.4010	2015-04-12
HOY	Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	Ophthalmic	Class 1	886.4750	2021-10-21
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2019-05-20
FYA	Gown, Surgical	General, Plastic Surgery	Class 2	878.4040	2013-01-23
OEA	Non-Surgical Gown	General, Plastic Surgery	Class 1	878.4040	2010-07-22
KYZ	Syringe, Irrigating (Non Dental)	General Hospital	Class 1	880.6960	2010-07-23
FWZ	Operating Room Accessories Table Tray	General, Plastic Surgery	Class 1	878.4950	2010-07-22
FXX	Mask, Surgical	General, Plastic Surgery	Class 2	878.4040	2021-12-05
FSM	Tray, Surgical, Instrument	General, Plastic Surgery	Class 1	878.4800	2010-07-22
FXP	Cover, Shoe, Operating-Room	General, Plastic Surgery	Class 1	878.4040	2020-07-13
HRP	Pen, Marking, Surgical	Ophthalmic	Class 1	886.4570	2015-01-30
EYQ	Garment, Protective, For Incontinence	Gastroenterology, Urology	Class 1	876.5920	2010-07-22
LZA	Polymer Patient Examination Glove	General Hospital	Class 1	880.6250	2021-12-14
LYU	Accessory, Surgical Apparel	General, Plastic Surgery	Class 1	878.4040	2010-07-22
HXD	Clamp	General, Plastic Surgery	Class 1	878.4800	2015-01-30
KKX	Drape, Surgical, Antimicrobial	General, Plastic Surgery	Class 2	878.4370	2021-08-16
FRG	Wrap, Sterilization	General Hospital	Class 2	880.6850	2022-03-10
FYF	Cap, Surgical	General, Plastic Surgery	Class 1	878.4040	2010-07-22
MSH	Respirator, Surgical	General, Plastic Surgery	Class 2	878.4040	2025-05-06
KME	Bedding, Disposable, Medical	General Hospital	Class 1	880.6060	2010-07-22
EXJ	Device, Incontinence, Urosheath Type, Sterile	Gastroenterology, Urology	Class 1	876.5250	2026-01-16
GES	Blade, Scalpel	General, Plastic Surgery	Class 1	878.4800	2015-01-30
GDY	Gauze/Sponge, Internal, X-Ray Detectable	General, Plastic Surgery	Class 1	878.4450	2015-01-30
HRQ	Hemostat	General, Plastic Surgery	Class 1	878.4800	2010-07-23

Official Correspondent

Bin Dong

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

Weihai Hongyu Nonwoven Fabric Products 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
K881095	CooperVision, Inc.	KOI(TM) INSTRUMENT TRAYS	1988-04-06
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-0036-2010	Alphatec Spine, Inc.	1	ROC Lumbar bolt caddy, Part Number: 81997-01-05. Sterilization container for ROC bolts/screws. Product is used to contain spinal implants.
Z-0020-04	Vital Concepts, Inc.	1	Huntington Instruments brand Irrigation Aspiration System with Single Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55040. Labeled as Manufactured for Huntington Instruments, Ogden Utah.
Z-0021-04	Vital Concepts, Inc.	1	Irrigation Aspiration System with Double Spike Tubing and 33 cm Probe, Disposable (single use only), sterile, latex free. Catalog # 55060. HYDRO-PRO brand labeled as sold by Vital Concepts, Inc., Grand Rapids, Michigan. Huntington Instruments brand labeled as Manufactured for Huntington Instruments, Ogden Utah. Quanta Technologies L.L.C. brand Manufactured for Quanta Technologies, L.L.C., Tucson, AZ. Catalogue # 55060-10 sold in Canada and labeled as Manufactured for Jac-Cell Medic, Dorval, Quebec.
Z-0022-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Irrigation Aspiration System with double Spike Tubing, no Probe, Disposable (single use only), sterile, latex free. Catalog # 55160. Vital Concepts, Inc., Grand Rapids, Michigan.
Z-0023-04	Vital Concepts, Inc.	1	HYDRO-PRO brand Suction-Irrigation System without Probe, Disposable (single use only), sterile, latex free. R-Med Re-Order # 55170R; Distributed by R-Med, Inc., Orgeon, OH

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008489813. Last updated year: 2026. Please use registration number 3008489813 when referencing this establishment in official correspondence.