Data / Medical devices / China / Jiangxi Hongda Medical Equipment Group Ltd.
Jiangxi Hongda Medical Equipment Group Ltd.: FDA-registered device maker in Nanchang Jiangxi, China, 7 510(k) clearances
Jiangxi Hongda Medical Equipment Group Ltd. is registered with the FDA (registration 3007392007) in Nanchang Jiangxi, China. It lists 8 device types. The FDA files 7 510(k) clearances under its listings, the newest dated October 14, 2021. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3007392007
- Address
- No.39 Yunqiao South Road, Yunqiao street, Jinxian County, Nanchang Jiangxi, China, 331700
- Owner or operator
- Jiangxi Hongda Medical Equipment Group LTD. (10072239)
- Roles
- Manufacturer
- First device listed
- November 17, 2020
- Registered through
- 2027
- Brand names listed
- Medical Nitrile Examination Gloves, Medical PVC Examination Gloves, Single-Use Medical Face Mask, Single-use protective clothing, Sterile Hypodermic Safety Syringes for Single Use, Sterile Single-use Infusion Set, Sterile Single-use Syringe with Needle, Sterile Syringe with Safety Needle
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Mask, Surgical | FXX | 2 | Manufacturer | accessdata.fda.gov |
| Needle, Hypodermic, Single Lumen | FMI | 2 | Manufacturer | accessdata.fda.gov |
| Non-Surgical Gown | OEA | 1 | Manufacturer | accessdata.fda.gov |
| Polymer Patient Examination Glove | LZA | 1 | Manufacturer | accessdata.fda.gov |
| Set, Administration, Intravascular | FPA | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Antistick | MEG | 2 | Manufacturer | accessdata.fda.gov |
| Syringe, Piston | FMF | 2 | Manufacturer | accessdata.fda.gov |
| Vinyl Patient Examination Glove | LYZ | 1 | 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 |
|---|---|---|---|---|---|---|
| October 14, 2021 | K211753 | Sterile Syringe With Safety Needle | MEG | Substantially Equivalent | Jiangxi Hongda Medical Equipment Group , Ltd. | accessdata.fda.gov |
| October 8, 2021 | K210622 | Single-Use Medical Face Mask | FXX | Substantially Equivalent | Jiangxi Hongda Medical Equipment Group Co., Ltd. | accessdata.fda.gov |
| July 10, 2021 | K210578 | Medical Nitrile Examination Gloves (Power free, Blue) | LZA | Substantially Equivalent | Jiangxi Hongda Medical Equipment Group , Ltd. | accessdata.fda.gov |
| July 9, 2021 | K210821 | Medical PVC Examination Gloves | LYZ | Substantially Equivalent | Jiangxi Hongda Medical Equipment Group , Ltd. | accessdata.fda.gov |
| April 20, 2017 | K163160 | Sterile Single-use Infusion Set | FPA | Substantially Equivalent | Jiangxi Hongda Medical Equipment Group , Ltd. | accessdata.fda.gov |
| March 20, 2017 | K163162 | Sterile Hypodermic Safety Syringes for Single Use | MEG | Substantially Equivalent | Jiangxi Hongda Medical Equipment Group , Ltd. | accessdata.fda.gov |
| March 20, 2017 | K163161 | Sterile Single-use Syringe with Needle | FMF | Substantially Equivalent | Jiangxi Hongda Medical Equipment Group , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Set, Administration, Intravascular
- All makers of Vinyl Patient Examination Glove
- All makers of Needle, Hypodermic, Single Lumen
- All makers of Syringe, Piston
- All makers of Polymer Patient Examination Glove
- All makers of Mask, Surgical
Updated October 14, 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.