Data / Medical devices / China / Nantong Egens Biotechnology Co.,ltd.
Nantong Egens Biotechnology Co.,ltd.: FDA-registered device maker in NANTONG Jiangsu, China, 4 510(k) clearances
Nantong Egens Biotechnology Co.,ltd. is registered with the FDA (registration 3006361161) in NANTONG Jiangsu, China. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 26, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3006361161
- Address
- Building 15, Building 12 (west), No. 1692 Xinghu Avenue Nantong Economy & Technology Development Zone, NANTONG Jiangsu, China, 226010
- Owner or operator
- NANTONG EGENS BIOTECHNOLOGY CO.,LTD. (9103205)
- Roles
- Exporter to the US, Manufacturer
- First device listed
- December 3, 2012
- Registered through
- 2026
- Brand names listed
- EGENS Follicle Stimulating Hormone (FSH) Test Cassette, EGENS Follicle Stimulating Hormone (FSH) Test Midstream, EGENS Follicle Stimulating Hormone (FSH) Test Strip, EGENS One Step HCG Urine Pregnancy Test Kit (Strip, Cassette, Midstream), EGENS Ovulation (LH) Test (strip, cassette, midstream), EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II, EGENS Urine Test Cup Morphine Methamphetamine EGENS Urine Test DipCard Morphine Methamphetamine and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Enzyme Immunoassay, Cannabinoids | LDJ | 2 | Manufacturer | accessdata.fda.gov |
| Gas Chromatography, Methamphetamine | LAF | 2 | Manufacturer | accessdata.fda.gov |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | 2 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | 1 | Manufacturer | accessdata.fda.gov |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | 1 | Manufacturer | accessdata.fda.gov |
| Thin Layer Chromatography, Morphine | DNK | 2 | Manufacturer | accessdata.fda.gov |
| Visual, Pregnancy Hcg, Prescription Use | JHI | 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 26, 2024 | K232864 | EGENS Pregnancy Test Midstream I, EGENS Pregnancy Test Midstream II | LCX | Substantially Equivalent | Nantong Egens Biotechnology Co., Ltd. | accessdata.fda.gov |
| November 2, 2015 | K152643 | EGENS Urine Test Cup THC-MDMA, EGENS Urine Test DipCard THC-MDMA, EGENS Urine Test Cassette Marijuana | LDJ | Substantially Equivalent | Nantong Egens Biotech Co., Ltd. | accessdata.fda.gov |
| July 16, 2015 | K151557 | EGENS Urine Test Cup Morphine - Methamphetamine, EGENS Urine DipCard Morphine - Methamphetamine | DNK | Substantially Equivalent | Nantong Egens Biotech Co., Ltd. | accessdata.fda.gov |
| February 5, 2013 | K123050 | EGENS ONE STEP HCG URINE PREGNANCY TEST KIT(S) (STRIP, CASSETTE, MIDSTREAM I AND MIDSTREAM II) | LCX | Substantially Equivalent | Nantong Biotechnology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Enzyme Immunoassay, Cannabinoids
- All makers of Gas Chromatography, Methamphetamine
- All makers of Test, Follicle Stimulating Hormone (Fsh), Over The Counter
- All makers of Kit, Test, Pregnancy, Hcg, Over The Counter
- All makers of Test, Luteinizing Hormone (Lh), Over The Counter
- All makers of Thin Layer Chromatography, Morphine
Updated January 26, 2024. 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.