Jiangsu Micsafe Medical Technology Co., Ltd
Yancheng Jiangsu, CN
JIANGSU MICSAFE MEDICAL TECHNOLOGY CO., LTD appears in FDA device records in Yancheng Jiangsu, CN. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Jiangsu Micsafe Medical Technology Co., Ltd between 2018 and 2021. The busiest year on record is 2021, with 3. The most recent is 2021, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2018 | 1 |
| 2019 | 1 |
| 2021 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| 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 | |
| K202570 | Insulin Syringe, Insulin Syringe with Safety Retractable | MEG | Substantially Equivalent | |
| K202205 | Surgical Face Mask | FXX | Substantially Equivalent | |
| K183665 | Safety Needles, Sterile Syringe, Sterile Syringe with Safety Needle, Sterile Syringe with Needle, Hypodermic Needle for Single Use | MEG | Substantially Equivalent | |
| K181426 | Oral/Enteral Syringe (10 mL to 60 mL) and Low Dose Tip Oral/Enteral Syringe (1 mL to 5 mL) | PNR | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3014570560 | 3014570560 | JIANGSU MICSAFE MEDICAL TECHNOLOGY CO., LTD | Xituan Industrial Park, Dafeng District, Yancheng Jiangsu 224125 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KYXDispenser, Liquid Medication
- PNREnteral Syringes With Enteral Specific Connectors
- FXXMask, Surgical
- GAANeedle, Aspiration And Injection, Disposable
- FMINeedle, Hypodermic, Single Lumen
- MEGSyringe, Antistick
- KYZSyringe, Irrigating (Non Dental)
- FMFSyringe, Piston
- KSTSystem, Blood Collection, Vacuum-Assisted, Manual
- JKATubes, Vials, Systems, Serum Separators, Blood Collection
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain