Jiangxi Hongda Medical Equipment Group Ltd.
Manufacturer and brand owner in Nanchang, Jiangxi, China. 8 device types, 2 products catalogued, 7 clearances.
Jiangxi Hongda Medical Equipment Group Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Mask, Surgical, Syringe, Piston and 6 other device types. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2020.
8device types registered with the FDA
2products catalogued under its own name
7510(k) clearances
Registration
| Registered name | JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007392007 |
| FEI number | 3007392007 |
| DUNS | 526963345 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 江西洪达医疗器械集团有限公司 |
|---|---|
| Unified social credit code | 9136012474429059X9 |
| Source | NMPA UDI database |
Location
| City | Nanchang |
|---|---|
| Province | Jiangxi |
| Address | No.39 Yunqiao South Road, Yunqiao street, Jinxian County |
| Postal code | 331700 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Mask, Surgical | Class 2 | Single-Use Medical Face Mask | 2021 | 125 |
| Needle, Hypodermic, Single Lumen | Class 2 | Sterile Single-use Syringe with Needle, Sterile Syringe with Safety Needle, Sterile Hypodermic Safety Syringes for Single Use | 2020 | 71 |
| Non-Surgical Gown | Class 1 | Single-use protective clothing | 2020 | 318 |
| Polymer Patient Examination Glove | Class 1 | Medical Nitrile Examination Gloves | 2021 | 83 |
| Set, Administration, Intravascular | Class 2 | Sterile Single-use Infusion Set | 2020 | 49 |
| Syringe, Antistick | Class 2 | Sterile Syringe with Safety Needle, Sterile Hypodermic Safety Syringes for Single Use | 2020 | 39 |
| Syringe, Piston | Class 2 | Sterile Single-use Syringe with Needle, Sterile Syringe with Safety Needle | 2020 | 60 |
| Vinyl Patient Examination Glove | Class 1 | Medical PVC Examination Gloves | 2021 | 72 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Sterile Single-use Syringe with Needle | FMI | 162 |
| Medical Nitrile Examination Gloves (Power free, Blue) | LZA | 10 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K211753 | 2021-10-14 | MEG | Traditional | This company |
| K210622 | 2021-10-08 | FXX | Traditional | This company |
| K210578 | 2021-07-10 | LZA | Traditional | This company |
| K210821 | 2021-07-09 | LYZ | Traditional | This company |
| K163160 | 2017-04-20 | FPA | Traditional | This company |
| K163162 | 2017-03-20 | MEG | Traditional | This company |
| K163161 | 2017-03-20 | FMF | Traditional | This company |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Nanchang White Technology Co., Ltd. | 21 |
| Jiangxi Yiles Medical Co., Ltd. | 13 |
| Nanchang Micare Medical Equipment Co., Ltd. | 8 |
| Jiangxi Partner Home Co., Ltd. | 7 |
| Jiangxi Vision Plus Medical Technology Co., Ltd. | 6 |
| Jiangxi Sanxin Medtec Co., Ltd. | 6 |
| Jiangxi 3L Medical Products Group Co., Ltd. | 6 |
| Jiangxi Glance Medical Equipment Co., Ltd. | 5 |
| Jiangxi Risun Technology Co., Ltd. | 3 |
| Jiangxi Yikang Medical Instrument Group Co., Ltd. | 2 |
| Nanchang Firstomato Medical Devices Co., Ltd. | 1 |
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.
The manufacturer named here can complete this record.