Jiangxi Hongda Medical Equipment Group Ltd.
Nanchang Jiangxi, CN
JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD. appears in FDA device records in Nanchang Jiangxi, CN. FDA records list 7 510(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 7 510(k) clearances for Jiangxi Hongda Medical Equipment Group Ltd. between 2017 and 2021. The busiest year on record is 2021, with 4. The most recent is 2021, with 4.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2017 | 3 |
| 2021 | 4 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K211753 | Sterile Syringe With Safety Needle | MEG | Substantially Equivalent | |
| K210622 | Single-Use Medical Face Mask | FXX | Substantially Equivalent | |
| K210578 | Medical Nitrile Examination Gloves (Power free, Blue) | LZA | Substantially Equivalent | |
| K210821 | Medical PVC Examination Gloves | LYZ | Substantially Equivalent | |
| K163160 | Sterile Single-use Infusion Set | FPA | Substantially Equivalent | |
| K163162 | Sterile Hypodermic Safety Syringes for Single Use | MEG | Substantially Equivalent | |
| K163161 | Sterile Single-use Syringe with Needle | FMF | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3007392007 | 3007392007 | JIANGXI HONGDA MEDICAL EQUIPMENT GROUP LTD. | No.39 Yunqiao South Road, Yunqiao street, Jinxian County, Nanchang Jiangxi 331700 CN | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
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