FDA Registration
Active
🇨🇳 China
NANTONG EGENS BIOTECHNOLOGY CO.,LTD.
Reg #: 3006361161
·
FEI: 3006361161
·
Expires 2026
Products
7
Proprietary Names
9
Establishment Types
2
Classifications
7
Registration Details
- Registration Name
- NANTONG EGENS BIOTECHNOLOGY CO.,LTD.
- Registration Number
- 3006361161
- FEI Number
- 3006361161
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Building 15, Building 12 (west), No. 1692 Xinghu Avenue, Nantong Economy & Technology Development Zone
- City
- NANTONG Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K152643
Owner / Operator
- Firm Name
- NANTONG EGENS BIOTECHNOLOGY CO.,LTD.
- Operator Number
- 9103205
- Address
- Building 15, Building 12 (west), No. 1692 Xinghu Avenue, Nantong Economy & Technology Development Zone
- City
- NANTONG
- State
- Jiangsu
- Postal Code
- 226010
- Country
- CN
- Correspondent
- LL - Su
US Agent
- Business Name
- LSI International Inc
- Contact Name
- Joe Xia
- Address
- 504E E Diamond Ave Suite I
- City
- Gaithersburg
- State
- MD
- ZIP
- 20878
- Country
- US
- [email protected]
- Phone
- 301 2500831
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Gas Chromatography, Methamphetamine | LAF | Class 2 | Clinical Toxicology | No | 2015-11-03 |
| Enzyme Immunoassay, Cannabinoids | LDJ | Class 2 | Clinical Toxicology | No | 2015-11-03 |
| Test, Follicle Stimulating Hormone (Fsh), Over The Counter | NGA | Class 1 | Clinical Chemistry | No | 2013-06-20 |
| Test, Luteinizing Hormone (Lh), Over The Counter | NGE | Class 1 | Clinical Chemistry | No | 2012-12-03 |
| Thin Layer Chromatography, Morphine | DNK | Class 2 | Clinical Toxicology | No | 2015-11-03 |
| Visual, Pregnancy Hcg, Prescription Use | JHI | Class 2 | Clinical Chemistry | No | 2013-02-18 |
| Kit, Test, Pregnancy, Hcg, Over The Counter | LCX | Class 2 | Clinical Chemistry | No | 2013-02-18 |
Proprietary Names
EGENS Urine Test Marijuana (THC) EGENS Urine Test MDMA
EGENS Follicle Stimulating Hormone (FSH) Test Midstream
EGENS Follicle Stimulating Hormone (FSH) Test Cassette
EGENS Follicle Stimulating Hormone (FSH) Test Strip
EGENS Ovulation (LH) Test (strip, cassette, midstream)
EGENS Urine Test Cup Morphine Methamphetamine EGENS Urine Test DipCard Morphine Methamphetamine
EGENS One Step HCG Urine Pregnancy Test Kit (Strip, Cassette, Midstream)
EGENS Pregnancy Test Midstream I
EGENS Pregnancy Test Midstream II
Establishment Types
Manufacture Medical Device
Export Device to the United States But Perform No Other Operation on Device