Data / Medical devices / China / Jiangsu Micsafe Medical Technology Co., Ltd
Jiangsu Micsafe Medical Technology Co., Ltd: FDA-registered device maker in Yancheng Jiangsu, China, 5 510(k) clearances
Jiangsu Micsafe Medical Technology Co., Ltd is registered with the FDA (registration 3014570560) in Yancheng Jiangsu, China. It lists 9 device types. The FDA files 5 510(k) clearances under its listings, the newest dated November 4, 2021. Registered through 2026. FDA data exported November 3, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3014570560
- Address
- Xituan Industrial Park, Dafeng District, Yancheng Jiangsu, China, 224125
- Owner or operator
- Jiangsu Micsafe Medical Technology Co., Ltd (10060296)
- Roles
- Manufacturer
- First device listed
- April 23, 2019
- Registered through
- 2026
- Brand names listed
- Blood Collection Needle, Blood Collection needle holder, Enteral syringe, GLUCO-CARE Insulin Syringes 0.3ml/cc, 31g x 5/16"(8mm); GLUCO-CARE Insulin Syringes 0.3ml/cc, 30G x 5/16"(8mm);, GLUCO-CARE Insulin Syringes 0.5ml/cc, 30G x 5/16"(8mm); GLUCO-CARE Insulin Syringes 1ml/cc, 31g x 5/16"(8mm), GLUCO-CARE Insulin Syringes 1ml/cc, 27G x 1/2"(12.7mm), GLUCO-CARE Insulin Syringes 1ml/cc, 30G x 5/16"(8mm); GLUCO-CARE Insulin Syringes 1ml/cc, 30G x 1/2"(12.7mm), Insulin Syringe with Safety Retractable and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dispenser, Liquid Medication | KYX | 1 | Manufacturer | accessdata.fda.gov |
| Enteral Syringes With Enteral Specific Connectors | PNR | 2 | 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 |
| Syringe, Antistick | MEG | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Irrigating (Non Dental) | KYZ | 1 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
| System, Blood Collection, Vacuum-Assisted, Manual | KST | 1 | 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 |
|---|---|---|---|---|---|---|
| November 4, 2021 | K212019 | Blood Collection Needle for Single Use & Blood Collection Needle with Holder for Single Use, Safety Blood Collection Needle for Single Use, Safety Blood Collection Needle with Holder for Single Use, Blood Collection Set for Single Use & Safety Blood Collection Set with Holder for Single Use, Safety Blood Collection Set for Single Use & Blood Collection Set with Holder for Single | JKA | Substantially Equivalent | Jiangsu Micsafe Medical Technology Co., Ltd. | accessdata.fda.gov |
| July 2, 2021 | K202570 | Insulin Syringe, Insulin Syringe with Safety Retractable | MEG | Substantially Equivalent | Jiangsu Micsafe Medical Technology Co., Ltd. | accessdata.fda.gov |
| September 6, 2019 | K183665 | Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use | MEG | Substantially Equivalent | Jiangsu Micsafe Medical Technology Co., Ltd. | accessdata.fda.gov |
| October 11, 2018 | K181426 | Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) | PNR | Substantially Equivalent | Jiangsu Micsafe Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 14, 2018 | K173279 | RELI Safety Blood Collection Tube Holder, RELI Blood Collection Tube Holder | FMI | Substantially Equivalent | Myco Medical Supplies, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Syringe, Antistick
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Irrigating (Non Dental)
- All makers of Needle, Aspiration And Injection, Disposable
- All makers of Enteral Syringes With Enteral Specific Connectors
- All makers of Tubes, Vials, Systems, Serum Separators, Blood Collection
Updated November 4, 2021. 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.