Zhejiang Hongyu Medical Commodity Co., Ltd.
Manufacturer and brand owner in Yiwu, Zhejiang, China. 36 device types, 5 products catalogued.
Zhejiang Hongyu Medical Commodity Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Crutch, Forceps and 34 other device types. 5 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2005.
36device types registered with the FDA
5products catalogued under its own name
Registration
| Registered name | ZHEJIANG HONGYU MEDICAL COMMODITY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3005083505 |
| FEI number | 3005083505 |
| DUNS | 526903301 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 浙江红雨医药用品有限公司 |
|---|---|
| Unified social credit code | 91330782734538344Y |
| Source | export sales certificate, Zhejiang medical products administration |
Location
| City | Yiwu |
|---|---|
| Province | Zhejiang |
| Address | No.668,ChanHua Road,Industrial Functional Area,Fotang Town |
| Postal code | 322002 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Face Shield, Month-To-Mouth Mast, Mask | 2006 | 439 |
| Adaptor, Dressing | Class 1 | Gloves | 2006 | 24 |
| Adhesive Backed Thermal Skin Patches | Class 1 | wellness patch; warm pad | 2023 | 48 |
| Applicator, Absorbent Tipped, Non-Sterile | Class 1 | Cotton Swabs, Non-Sterile | 2006 | 186 |
| Applicator, Absorbent Tipped, Sterile | Class 1 | Nasal Swab | 2022 | 100 |
| Bandage, Elastic | Class 1 | Bandage, Elastic | 2006 | 280 |
| Bandage, Liquid, Skin Protectant | Class 1 | liquid bandage | 2017 | 41 |
| Bedding, Disposable, Medical | Class 1 | Trauma Pad,Non-Adherent Pad, Non-Stick Pad,First Aid Blanket | 2006 | 308 |
| Continuous Measurement Thermometer | Class 2 | Digital Thermometer | 2025 | 115 |
| Crutch | Class 1 | Crutch | 2021 | 112 |
| Depressor, Tongue, Non-Surgical | Class 1 | tongue depressor | 2023 | 100 |
| Device, Fixation, Tracheal Tube | Class 1 | tender grips | 2017 | 46 |
| Dilator, Nasal | Class 1 | Nasal Dilator, Dilator, Nasal | 2015 | 55 |
| Disinfectant, Medical Devices | Class 1 | Alcohol Prep Pad/Cleansing Pads,BZK Antiseptic Swab, Sting Relief Wipe, Povidone Iodine Wipe | 2006 | 197 |
| Dispenser, Solid Medication | Class 1 | Pill BOX | 2026 | 68 |
| Dressing, Wound, Hydrophilic | Class 1 | Alginate Dressings; foam dressing, hydrogel dressing,I.V. dressing;Wound Dressing,Hydrocollid dressing, PIMPLE PATCH / Acne and Spot Patches/Blister patches, CMC Gelling Fiber Dressing | 2006 | 195 |
| Dressing, Wound, Occlusive | Class 1 | PIMPLE PATCH / Acne and Spot Patches/Blister patches, incise film, Silicone Superabsorbent Dressing, Silicone Wound Contact Layer | 2019 | 183 |
| Elastomer, Silicone, For Scar Management | Class 1 | Elastomer, Silicone, For Scar Management – Scar Gel,Silicone Dressing ,Silicone Tape | 2015 | 85 |
| Fiber, Medical, Absorbent | Class 1 | ABD Combine Pad, 5” x 9” | 2024 | 172 |
| First Aid Kit With Drug | Class N | 30 pcs, 40 pcs, 50 pcs | 2020 | 57 |
| First Aid Kit Without Drug | Class 1 | Hongyu First aid kit without drug, instrument cases, first aid case, 10788 baby healthcare kit | 2011 | 132 |
| Forceps | Class 1 | Hongyu FORCEPS | 2006 | 99 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze Pad, Gauze Dressing Pads, Cotton Ball, PVA lap sponges,PVA swab | 2006 | 266 |
| Instrument, Manual, Surgical, General Use | Class 1 | Safety Pin | 2006 | 110 |
| Mask, Scavenging | Class 1 | Disposable Medical Face Mask, KN95 Face Mask, Surgical Face Mask | 2020 | 158 |
| Mask, Surgical | Class 2 | Non-Sterile Disposable Surgical Face Mask-Level 3 | 2021 | 125 |
| Non-Surgical Gown | Class 1 | Disposable Isolation | 2020 | 318 |
| Pack, Hot Or Cold, Disposable | Class 1 | cooling patch, Instant Hot Pack | 2006 | 176 |
| Pack, Hot Or Cold, Reusable | Class 1 | Instant Hot Pack | 2008 | 178 |
| Pad, Eye | Class 1 | Eye Pad | 2006 | 100 |
| Scissors, General, Surgical | Class 1 | Hongyu SCISSORS | 2006 | 83 |
| Sling, Arm | Class 1 | Triangular Bandage | 2006 | 126 |
| Support, Arm | Class 1 | Shoulder Cushion | 2025 | 72 |
| Tape And Bandage, Adhesive | Class 1 | Hongyu Tape and bandage, adhesive, corn plaster, Plaster | 2005 | 353 |
| Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use | Class 1 | band-aid | 2024 | 13 |
| Tourniquet, Nonpneumatic | Class 1 | Tourniquet | 2024 | 124 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| smileplus | KGX | 1 |
| YoveCare | MDA | 1 |
| Medi Grade | NAD | 1 |
| Hongyu | KGX | 1 |
| Medi Grade | LWF | 1 |
Clearances
No clearance names Zhejiang Hongyu Medical Commodity Co., Ltd. as applicant. One 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 |
|---|---|---|---|---|
| K211897 | 2021-08-03 | FXX | Traditional | Zhejiang Hongyu Medicali Commodity Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2002 |
|---|---|
| Employees | 400+ |
| Factory area | 54000 square meters |
| Main products | plasters, cotton swabs, kinesiology tape, pimple patches, first aid kits |
| Certifications | CE, ISO 13485:2016, FDA |
| Export markets | 80+ countries across 6 continents |
| OEM and ODM | Offered |
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.