Yangzhou Medline Industry Co., Ltd.
Registered establishment in Yangzhou, Jiangsu, China. 11 device types, 2 clearances.
Yangzhou Medline Industry Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Syringe, Piston, Syringe, Antistick and 9 other device types. Its earliest product listing with the FDA dates from 2024.
11device types registered with the FDA
2510(k) clearances
Registration
| Registered name | YANGZHOU MEDLINE INDUSTRY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3034667025 |
| FEI number | 3034667025 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Yangzhou |
|---|---|
| Province | Jiangsu |
| Address | No.99, South Yangzi Road, Yangzhou, 225000 Jiangsu, P.R.China |
| Postal code | 225000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Brush, Scrub, Operating-Room | Class 1 | Surgical Scrub Brush | 2025 | 42 |
| Container, Liquid Medication, Graduated | Class 1 | Oral Syringes, Oral Tip Caps | 2024 | 68 |
| Container, Specimen, Sterile | Class 1 | Blood Transfer Unit, Blood Transfer Adapter, Sample Transfer Unit, Disposable Blood Transfer Unit, Plasma Transfer Unit | 2024 | 79 |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | Class 1 | Needle Holder, Safety Needle Holder | 2024 | 72 |
| Needle, Aspiration And Injection, Disposable | Class 1 | Blunt Fill Needle, Filter Needles, Blood Fill Needle W/O Filter, Blunt Needles W/O Filter | 2024 | 37 |
| Needle, Hypodermic, Single Lumen | Class 2 | Sterile Safety Syringe, Sterile Disposable Syringe with Needle, Sterile Disposable Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Syringe with Safety Needle | 2024 | 71 |
| Respirator, Surgical | Class 2 | Respiratory Protective Mask, I9501, II9501 | 2024 | 118 |
| Syringe, Antistick | Class 2 | Safety Syringe With/Without Needle, Safety Insulin Syringe, Sterile Safety Syringe, Sterile Disposable Syringe with Needle, Sterile Disposable Needle, Sterile Disposable Syringe and 2 more | 2024 | 39 |
| Syringe, Irrigating (Non Dental) | Class 1 | Irrigation Syringe | 2024 | 110 |
| Syringe, Piston | Class 2 | Sterile Safety Syringe, Sterile Disposable Syringe with Needle, Sterile Disposable Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Syringe with Safety Needle | 2024 | 60 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | Class 2 | Safety Blood Collection Needle with Holder,, Blood Collection Needle with Holder, Safety Blood Collection Needle, Safety Blood Collection Set with Holder, Blood Collection Needle, Luer Adapter with Holder, Safety Blood Collection Set and 2 more | 2024 | 23 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K230080 | 2023-07-07 | JKA | Traditional | This company |
| K170651 | 2017-08-02 | MEG | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2006 |
|---|---|
| Factory area | 30000 m2 |
| Main products | Safety syringes, Blood collection series, Diabetes care solutions, Infusion series, Surgical consumables |
| Certifications | ISO13485, CE, FDA 510K, CFDA, TGA |
| Export markets | United States, Europe, South Korea, Asia, South America, North America, Africa, Australia |
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.