Weihai Hongyu Nonwoven Fabric Products Co., Ltd.
Manufacturer and brand owner in Weihai, Shandong, China. 37 device types, 1 product catalogued, 6 clearances.
Weihai Hongyu Nonwoven Fabric Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Clamp, Forceps and 35 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2010.
37device types registered with the FDA
1product
6510(k) clearances
Registration
| Registered name | Weihai Hongyu Nonwoven Fabric Products Co.,Ltd |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3008489813 |
| FEI number | 3008489813 |
| DUNS | 421260215 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 威海鸿宇无纺布制品有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Weihai |
|---|---|
| Province | Shandong |
| Address | No.19-8 |
| Postal code | 264205 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | leg Sets, Sleeve, Hand Towel 05579, Hand Towel 14.625*27 | 2010 | 439 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | Class 1 | Nasal Aspirator | 2015 | 58 |
| Basin, Emesis | Class 1 | Basin | 2010 | 65 |
| Bedding, Disposable, Medical | Class 1 | Pillowcase, Bedsheet, Bed Bag | 2010 | 308 |
| Blade, Scalpel | Class 1 | Scalpel 11# | 2015 | 41 |
| Brush, Scrub, Operating-Room | Class 1 | Sponge Brush | 2010 | 42 |
| Cap, Surgical | Class 1 | Surgical Cap | 2010 | 178 |
| Clamp | Class 1 | Towel Clip | 2015 | 24 |
| Clamp, Umbilical | Class 2 | Umbilical Clamp | 2015 | 14 |
| Container, Liquid Medication, Graduated | Class 1 | Meter Glass, lodine container | 2010 | 68 |
| Cover, Mattress (Medical Purposes) | Class 1 | Bedcover | 2010 | 89 |
| Cover, Shoe, Operating-Room | Class 1 | Isolation Shoe Covers | 2020 | 176 |
| Device, Incontinence, Urosheath Type, Sterile | Class 1 | Disposable Adult Diapers;, adult brief | 2026 | 4 |
| Drape, Surgical, Antimicrobial | Class 2 | Disposable Surgical Drapes, Surgical Drape, Surgical Wrap | 2014 | 39 |
| Dress, Surgical | Class 1 | Dress | 2010 | 71 |
| Forceps | Class 1 | Hemostat 125mm, Forceps | 2010 | 99 |
| Garment, Protective, For Incontinence | Class 1 | Diaper | 2010 | 181 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze, Checking Pad, Sterile Towl, Gauze 4*4-12P, Sponge | 2010 | 266 |
| Gauze/Sponge, Internal, X-Ray Detectable | Class 1 | Ray Gauze 10*10cm, 16P | 2015 | 67 |
| Gown, Surgical | Class 2 | Disposable Surgical Drapes, Level 4 Surgical Gowns, Level 3 surgical gowns | 2013 | 68 |
| Hemostat | Class 1 | Hemostat | 2010 | 12 |
| Instrument, Surgical, Disposable | Class 1 | Laparoscopic Herniorrhaphy Pack Ophthalmic Pack Parturition Pack Newborn Pack Ophthalmic Pack, Small Prep Tray, Intervention Pack EENT Pack Cardiac Intervention Pack Cesarean Section Pack Basic Pack Cystoscopy Pack Lithotomy Pack, Wrapping Cloth Suture Needle Bag Mayo Stand Cpver Equipment Cover Guidewire Bowl Basin 1000ml Protecting Sheet(SMS), Shoulder Articulation Pack Arthroscopy Pack Orthopedic Pack Bilateral Split Pack Universal Pack Upper Extremity Pack | 2015 | 45 |
| Iodine (Tincture) | Class 1 | 7.5% lodine 10% lodine | 2015 | 5 |
| Mask, Surgical | Class 2 | Surgical Masks | 2021 | 125 |
| Non-Surgical Gown | Class 1 | Non-surgical isolation gown, Disposable Medical Protective Clothing | 2010 | 318 |
| Operating Room Accessories Table Tray | Class 1 | Head Rest Cover | 2010 | 25 |
| Pen, Marking, Surgical | Class 1 | Medical Masker | 2015 | 2 |
| Polymer Patient Examination Glove | Class 1 | Nitrile Examination Gloves | 2021 | 83 |
| Respirator, Surgical | Class 2 | Medical Mask N95 | 2025 | 118 |
| Scalpel, One-Piece | Class 1 | Scalpel | 2010 | 14 |
| Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) | Class 1 | face shield | 2021 | 384 |
| Skin Prep Tray | Class 1 | Skin Scrub Tray | 2016 | 8 |
| Syringe, Irrigating (Non Dental) | Class 1 | Syringe 3ml, Syringe 10ml, General syringe, Syringe 20ml | 2010 | 110 |
| Tape And Bandage, Adhesive | Class 1 | Adhesive | 2015 | 353 |
| Tray, Surgical | Class 1 | Kidney Tray | 2015 | 36 |
| Tray, Surgical, Instrument | Class 1 | Bowl:Kidney Tray | 2010 | 105 |
| Wrap, Sterilization | Class 2 | Sterilization wraps, CSR Wrap | 2019 | 38 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Disposable Surgical Gowns | FYA | 2 |
Clearances
6 clearances name Weihai Hongyu Nonwoven Fabric Products Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K214088 | 2022-04-12 | FYA | Traditional | This company |
| K220133 | 2022-03-10 | FRG | Traditional | This company |
| K213029 | 2021-12-14 | LZA | Traditional | This company |
| K212807 | 2021-12-03 | FXX | Traditional | This company |
| K141324 | 2015-04-14 | KKX | Traditional | This company |
| K120192 | 2012-10-16 | FYA | Traditional | This company |
| K964142 | 1997-02-25 | KKX | Traditional | Medline Industries, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Factory area | 50000 sqm |
| Main products | Surgical drapes, Surgical gowns, Isolation gowns, Masks, Surgical instrument sets |
| Certifications | ISO13485, CE, FDA |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.