Huaian Hening Medical Instruments Co., Ltd. And Its Subsidiary Huaian Junran IMP.&EXP. Trading Co., Ltd.
Registered establishment in Huaian, Jiangsu, China. 4 device types.
Huaian Hening Medical Instruments Co., Ltd. and its Subsidiary Huaian Junran IMP.&EXP. Trading Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Pad, Alcohol, Device Disinfectant, Multiple Use Blood Lancet For Single Patient Use Only and 2 other device types. Its earliest product listing with the FDA dates from 2013.
Registration
| Registered name | HUAIAN HENING MEDICAL INSTRUMENTS CO., LTD and its Subsidiary HUAIAN JUNRAN IMP.&EXP. TRADING CO.,LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3006899020 |
| FEI number | 3006899020 |
| Establishment type | Contract manufacturer, Private-label distributor, Manufacturer, Exporter |
Location
| City | Huaian |
|---|---|
| Province | Jiangsu |
| Address | NO.6 West Hongdou Road Economic Development Zone |
| Postal code | 223005 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Multiple Use Blood Lancet For Single Patient Use Only | Class 2 | Easy Comfort Lancets, Pro Comfor Lancets, True Comfort Lancets, Pure Comfort Lancets, True Comfort Pro Lancets | 2023 | 21 |
| Pad, Alcohol, Device Disinfectant | Class U | Pro Comfort Alcohol prep pads, True Comfort Alcohol Prep Pads, True Comfort Pro Alcohol Prep Pads | 2015 | 49 |
| Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature | Class 2 | Easy Comfort Lancets, True Comfort Lancets, Pro Comfor Lancets, True Comfort Pro, Pure Comfort Safety Lancets | 2013 | 36 |
| Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature | Class 2 | Easy Comfort Lancets, Pro Comfor Lancets, True Comfort Lancets, Pure Comfort Lancets, True Comfort Pro Lancets | 2023 | 21 |
Clearances
No clearance names Huaian Hening Medical Instruments Co., Ltd. and its Subsidiary Huaian Junran IMP.&EXP. Trading Co., Ltd. as applicant. 2 are held by another company and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K223314 | 2023-01-25 | QRK | Traditional | Huaian Hening Medical Instruments Co., Ltd. |
| K223313 | 2023-01-23 | FMK | Traditional | Huaian Hening Medical Instruments Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2010 |
|---|---|
| Main products | Blood collection needles, Umbilical cord clips, Alcohol tablets |
| Certifications | ISO9001, ISO13485, CE, FDA 510K |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Asol Co., Ltd. | 22 |
| Huaian Tisurg Medical Instruments Co., Ltd. | 22 |
| Huaian Frimen Co., Ltd. | 16 |
| Huaian Wolfram Surgical Instruments | 14 |
| Huaian Angel Medical Instrument Co., Ltd. | 11 |
| Huaian Youwen Medical Technology Co., Ltd. | 6 |
| Huaian Mimir Electric Appliance Co., Ltd. | 2 |
| Jiangsu Youxin ICE Pack Co., Ltd. | 2 |
| Huaian Zhongxin Packing Material 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.