Data / Medical devices / China / HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD and its Subsidiary HUAIAN JUNRAN IMP.&EXP. TRADING CO.,LTD
HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD and its Subsidiary HUAIAN JUNRAN IMP.&EXP. TRADING CO.,LTD: FDA-registered device maker in Huaian Jiangsu, China, 2 510(k) clearances
HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD and its Subsidiary HUAIAN JUNRAN IMP.&EXP. TRADING CO.,LTD is registered with the FDA (registration 3006899020) in Huaian Jiangsu, China. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 25, 2023. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3006899020
- Address
- NO.6 West Hongdou Road Economic Development Zone, Huaian Jiangsu, China, 223005
- Owner or operator
- HOME AIDE DIAGNOSTICS, INC. (9087599)
- Roles
- Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- October 30, 2013
- Registered through
- 2027
- Brand names listed
- Easy Comfort Lancets, Pro Comfor Lancets, Pro Comfort Alcohol prep pads, Pure Comfort Lancets, Pure Comfort Safety Lancets, True Comfort Alcohol Prep Pads, True Comfort Lancets, True Comfort Pro and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Multiple Use Blood Lancet For Single Patient Use Only | QRL | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Pad, Alcohol, Device Disinfectant | LKB | U | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | FMK | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | QRK | 2 | Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| January 25, 2023 | K223314 | Disposable Blood Lancets | QRK | Substantially Equivalent | Huaian Hening Medical Instruments Co., Ltd. | accessdata.fda.gov |
| January 23, 2023 | K223313 | Disposable Safety Lancets | FMK | Substantially Equivalent | Huaian Hening Medical Instruments Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature
- All makers of Pad, Alcohol, Device Disinfectant
- All makers of Multiple Use Blood Lancet For Single Patient Use Only
- All makers of Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature
Updated January 25, 2023. 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.