Jiangsu Micsafe Medical Technology Co., Ltd.
Registered establishment in Yancheng, Jiangsu, China. 9 device types, 5 clearances.
Jiangsu Micsafe Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Syringe, Piston, Syringe, Antistick and 7 other device types. Its earliest product listing with the FDA dates from 2019.
Registration
| Registered name | JIANGSU MICSAFE MEDICAL TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014570560 |
| FEI number | 3014570560 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 江苏迈硕医疗科技有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Yancheng |
|---|---|
| Province | Jiangsu |
| Address | Xituan Industrial Park, Dafeng District |
| Postal code | 224125 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Dispenser, Liquid Medication | Class 1 | 2019 | 86 | |
| Enteral Syringes With Enteral Specific Connectors | Class 2 | Enteral syringe | 2019 | 13 |
| Needle, Aspiration And Injection, Disposable | Class 1 | 2020 | 37 | |
| Needle, Hypodermic, Single Lumen | Class 2 | Insulin syringe, Insulin Syringe with Safety Retractable, GLUCO-CARE Insulin Syringes 1ml/cc, 27G x 1/2″(12.7mm), 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 1ml/cc, 30G x 5/16″(8mm); GLUCO-CARE Insulin Syringes 1ml/cc, 30G x 1/2″(12.7mm), ONE-CARE® Insulin Safety Syringe,1mL, 29G x 1/2’’; ONE-CARE TB Safety Syringe, 1mL, 27G x 1/2’’ and 5 more | 2019 | 71 |
| Syringe, Antistick | Class 2 | Insulin syringe, Insulin Syringe with Safety Retractable, GLUCO-CARE Insulin Syringes 1ml/cc, 27G x 1/2″(12.7mm), 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 1ml/cc, 30G x 5/16″(8mm); GLUCO-CARE Insulin Syringes 1ml/cc, 30G x 1/2″(12.7mm), ONE-CARE® Insulin Safety Syringe,1mL, 29G x 1/2’’; ONE-CARE TB Safety Syringe, 1mL, 27G x 1/2’’ and 4 more | 2019 | 39 |
| Syringe, Irrigating (Non Dental) | Class 1 | Irrigating Syringe | 2023 | 110 |
| Syringe, Piston | Class 2 | Safety Hypodermic Needle, ONE-CARE Luer-Lock Syringes 1ml; ONE-CARE Luer-Lock Syringes 3ml, ONE-CARE Luer-Lock Syringes 5ml; ONE-CARE Luer-Lock Syringes 10ml | 2019 | 60 |
| System, Blood Collection, Vacuum-Assisted, Manual | Class 1 | Safety Blood Collection needle holder, Blood Collection needle holder | 2021 | 31 |
| Tubes, Vials, Systems, Serum Separators, Blood Collection | Class 2 | Blood Collection Needle | 2021 | 23 |
Clearances
5 clearances name Jiangsu Micsafe Medical Technology Co., Ltd. as applicant. 1 is held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K212019 | 2021-11-04 | JKA | Traditional | This company |
| K202570 | 2021-07-02 | MEG | Traditional | This company |
| K202205 | 2021-03-09 | FXX | Traditional | This company |
| K183665 | 2019-09-06 | MEG | Traditional | This company |
| K181426 | 2018-10-11 | PNR | Traditional | This company |
| K173279 | 2018-05-14 | FMI | Traditional | Myco Medical Supplies, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2013 |
|---|---|
| Factory area | 101000 square meters |
| Main products | Medical syringes, Insulin syringes, Hypodermic needles, Blood collection needles |
| Certifications | FDA, CE, ISO13485, ISO9001, UKCA, MHRA, TGA |
| Export markets | USA, UK, Canada, Europe, 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.
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