Data / Medical devices / China / Yangzhou Medline Industry Co., Ltd.
Yangzhou Medline Industry Co., Ltd.: FDA-registered device maker in Yangzhou Jiangsu, China, 2 510(k) clearances
Yangzhou Medline Industry Co., Ltd. is registered with the FDA (registration 3034667025) in Yangzhou Jiangsu, China. It lists 11 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 7, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3034667025
- Address
- No.99, South Yangzi Road, Yangzhou, 225000 Jiangsu, P.R.China, Yangzhou Jiangsu, China, 225000
- Owner or operator
- Yangzhou Medline Industry Co., Ltd. (10092036)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 27, 2024
- Registered through
- 2026
- Brand names listed
- Blood Collection Needle with Holder, Blood Collection Set, Blood Collection Set with Holder, Blood Fill Needle W/O Filter, Blunt Needles W/O Filter, Blood Transfer Unit, Blood Transfer Adapter, Sample Transfer Unit, Disposable Blood Transfer Unit, Plasma Transfer Unit, Blunt Fill Needle, Filter Needles, Irrigation Syringe, Luer Adapter with Holder and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Scrub, Operating-Room | GEC | 1 | Manufacturer | accessdata.fda.gov |
| Container, Liquid Medication, Graduated | KYW | 1 | Manufacturer | accessdata.fda.gov |
| Container, Specimen, Sterile | FMH | 1 | Manufacturer | accessdata.fda.gov |
| Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use | LXG | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Aspiration And Injection, Disposable | GAA | 1 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | JKA | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 7, 2023 | K230080 | Blood Collection Set, Blood Collection Set with Holder, Safety Blood Collection Set, Safety Blood Collection Set with Holder, Blood | JKA | Substantially Equivalent | Yangzhou Medline Industry, Co., Ltd. | accessdata.fda.gov |
| August 2, 2017 | K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Disposable Syringe with Needle, Sterile Disposable Syringe, Sterile Disposable Safety Needle, Sterile Disposable Needle | MEG | Substantially Equivalent | Yangzhou Medline Industry, Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of Syringe, Antistick
- All makers of Container, Specimen, Sterile
- All makers of Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use
Updated July 7, 2023. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.