Data / Medical devices / China / Jiangsu Caina Medical Co., Ltd
Jiangsu Caina Medical Co., Ltd: FDA-registered device maker in Jiangyin Jiangsu, China, 11 510(k) clearances
Jiangsu Caina Medical Co., Ltd is registered with the FDA (registration 3005670221) in Jiangyin Jiangsu, China. It lists 20 device types. The FDA files 11 510(k) clearances under its listings, the newest dated March 7, 2024. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3005670221
- Address
- No.23, Huanxi Road, Zhutang Town, Jiangyin Jiangsu, China, 214415
- Owner or operator
- Jiangsu Caina Medical Co., Ltd (10038768)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- January 14, 2016
- Registered through
- 2026
- Brand names listed
- BLUNT CANNULA, Blood Collection Needle with/without Holder, Blood Collection Tube Holder, Disposable Sterile Needle, ENFit Oral / Enteral Syringe, ENFit Syringe,ENFit Syringe cap, ENFit Tip Irrigation Syringe, Insulin Safety Syringe and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| March 7, 2024 | K232781 | Safety Sliding Blood Collection Set | JKA | Substantially Equivalent | Jiangsu Caina Medical Co.,Ltd | accessdata.fda.gov |
| June 2, 2023 | K230635 | Pen Needle | FMI | Substantially Equivalent | Jiangsu Caina Medical Co.,Ltd | accessdata.fda.gov |
| July 21, 2022 | K220184 | Pump Alignment Syringe | FMF | Substantially Equivalent | Jiangsu Caina Medical Co.,Ltd | accessdata.fda.gov |
| April 7, 2021 | K200463 | Huber Needle Infusion Set, Safety Huber Needle Infusion Set | PTI | Substantially Equivalent | Jiangsu Caina Medical Co.,Ltd | accessdata.fda.gov |
| February 12, 2021 | K201356 | Plastic LOR Syringe | CAZ | Substantially Equivalent | Jiangsu Caina Medical Co.,Ltd | accessdata.fda.gov |
| September 9, 2020 | K200027 | Blood Collection Needle with/without Holder, Safety Blood Collection Needle with/without Holder, Luer Access Device-holder with Preattached Multiple Sample Adapter | JKA | Substantially Equivalent | Jiangsu Caina Medical Co.,Ltd | accessdata.fda.gov |
| July 17, 2020 | K193526 | Syringe with safety needle, Safety needle | FMF | Substantially Equivalent | Jiangsu Caina Medical Co.,Ltd | accessdata.fda.gov |
| October 3, 2019 | K191490 | Retractable Safety Syringe, Retractable Safety Insulin Syringe, Retractable Safety Tuberculin Syringe, Retractable Safety Allergy Syringe | MEG | Substantially Equivalent | Jiangsu Caina Medical Co.,Ltd | accessdata.fda.gov |
| August 6, 2019 | K190502 | ENFit Oral / Enteral Syringe | PNR | Substantially Equivalent | Jiangsu Caina Medical Co.,Ltd | accessdata.fda.gov |
| December 14, 2018 | K181374 | NRFit Syringe | QEH | Substantially Equivalent | Jiangsu Caina Medical Co.,Ltd | accessdata.fda.gov |
| June 14, 2018 | K172938 | Disposable Sterile Needle | FMI | Substantially Equivalent | Jiangsu Caina Medical Co.,Ltd | accessdata.fda.gov |
Compare with other makers
- All makers of Non-Coring (Huber) Needle
- All makers of Set, Administration, Intravascular
- All makers of Syringe, Irrigating (Non Dental)
- All makers of Syringe, Periodontic, Endodontic, Irrigating
- All makers of Tube, Double Lumen For Intestinal Decompression And/Or Intubation
- All makers of Needle, Aspiration And Injection, Disposable
Updated March 7, 2024. 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.