Wuhan Zonsen Medical Products Co., Ltd.
Registered establishment in Wuhan, Hubei, China. 24 device types, 6 clearances.
Wuhan Zonsen Medical Products Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cotton, Roll, Cap, Surgical and 22 other device types. Its earliest product listing with the FDA dates from 2018.
24device types registered with the FDA
6510(k) clearances
Registration
| Registered name | WUHAN ZONSEN MEDICAL PRODUCTS CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3015140351 |
| FEI number | 3015140351 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 武汉中森医疗用品有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Wuhan |
|---|---|
| Province | Hubei |
| Address | No. 8 Jinchao Road, Zhucheng Street, Xinzhou District |
| Postal code | 431000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Accessory, Surgical Apparel | 2018 | 439 |
| Bandage, Elastic | Class 1 | High elastic bandage, Elastic tubular bandage, Crepe bandage | 2021 | 280 |
| Bedding, Disposable, Medical | Class 1 | Bedding, Disposable, Medical, Underpad | 2018 | 308 |
| Brush, Scrub, Operating-Room | Class 1 | Operating Room Towels | 2021 | 42 |
| Cap, Surgical | Class 1 | ZONSEN1 | 2021 | 178 |
| Component, Cast | Class 1 | Plaster of Paris bandage | 2021 | 22 |
| Cotton, Roll | Class 1 | Cotton roll, Dental cotton | 2021 | 107 |
| Cover, Shoe, Operating-Room | Class 1 | Cover, Shoe, Operating-Room | 2018 | 176 |
| Disinfectant, Medical Devices | Class 1 | Alcohol Prep PAD; BZK PAD; Cleansing Wipe; Nonwoven PAD; OB Towolette | 2019 | 197 |
| Drape, Surgical, Exempt | Class 2 | Drape, Surgical, Exempt | 2020 | 107 |
| Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua | Class N | Face Mask | 2021 | 182 |
| First Aid Kit With Drug | Class N | First Aid Kit | 2023 | 57 |
| Gauze / Sponge,Nonresorbable For External Use | Class 1 | Gauze roll, Gauze sponge, Gauze Bandage, Gauze lap sponge, Gauze ball, Non-woven sponge, Eye pad | 2021 | 266 |
| Gown, Examination | Class 1 | Gown, Examination | 2018 | 109 |
| Gown, Isolation, Surgical | Class 2 | Surgical Isolation Gown | 2022 | 21 |
| Gown, Surgical | Class 2 | Surgical gown, model ZSG1005, Reinforced surgical gown, model ZSG1006, Level 4 surgical gown, Level 2 and Level 3 Surgical gown | 2021 | 68 |
| Mask, Scavenging | Class 1 | Mask, Scavenging | 2019 | 158 |
| Mask, Surgical | Class 2 | Surgical Mask, Mask, Surgical, Medline Surgical Masks | 2020 | 125 |
| Non-Surgical Gown | Class 1 | Non-surgical isolation gown, nonwoven hood, lab coat, boot cover, trousers, beard cover and 1 more | 2018 | 318 |
| Pad, Menstrual, Unscented | Class 1 | Perineal cooling liners | 2023 | 132 |
| Polymer Patient Examination Glove | Class 1 | Nitrile Examination Gloves (Model: ZMG1351) | 2022 | 83 |
| Suit, Surgical | Class 1 | Suit, Surgical | 2018 | 74 |
| Tape And Bandage, Adhesive | Class 1 | Elastic adhesive bandage, Cohesive bandage | 2021 | 353 |
| Wrap, Sterilization | Class 2 | CSR Wrap, Sterilization Wrap, Gemini Sterilization Wrap, Model GEM5145S, GEM5145T, GEM5148T, GEM5154T | 2023 | 38 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K223600 | 2023-08-25 | FRG | Traditional | This company |
| K213601 | 2022-12-16 | FXX | Traditional | This company |
| K213688 | 2022-02-18 | LZA | Traditional | This company |
| K212357 | 2022-01-20 | FYC | Traditional | This company |
| K212861 | 2021-12-15 | FYA | Traditional | This company |
| K202191 | 2021-03-29 | FXX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1998 |
|---|---|
| Employees | 4500 |
| Factory area | 400,000㎡ |
| Main products | disposable protective articles, surgical coveralls, non-woven uniforms, surgical drapes, lab coats |
| Certifications | ISO 9001, ISO13485, BSCI, FDA cGMP |
| Export markets | 50+ countries: Japan, Germany, France, UK, Italy, Spain, USA, Canada, Australia, New Zealand, South America, Middle East |
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.