Nantong Egens Biotechnology Co L T D

FDA Filings

This page includes the latest FDA filings for Nantong Egens Biotechnology Co L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3006361161
• FEI Number: 3006361161
• Name: NANTONG EGENS BIOTECHNOLOGY CO.,LTD.
• Owner & Operator: NANTONG EGENS BIOTECHNOLOGY CO.,LTD.
• Contact Address: Building 15, Building 12 (west), No. 169 Nantong Economy & Technology Development; NANTONG CN-32 Jiangsu 226010 CN
• Official Correspondent:
  • ADA - WANG
  • 86-513-85327458-x
• US Agent:
  • Joe Xia
  • LSI
  • 301 2500831
  • jxia@lsi-consulting.org
• Importing Logistics Registration:
  • Importer: BC TRADE LLC
  • Address: 1861 Polk Street Ste,4 ; Chattanooga, TN 37408 UNITED STATES
  • Phone: 1 904 6519331
• Importing Logistics Registration:
  • Importer: Daxin Company
  • Address: 1055 Tustin Pines Way ; Tustin, CA 92780 UNITED STATES
  • Phone: 1 706 2485805
• Importing Logistics Registration:
  • Importer: Discount Diagnostics LLC
  • Address: 4747 Oceanside Blvd Suite F ; Oceanside, CA 92056 UNITED STATES
  • Importer Type: RETAILER
• Importing Logistics Registration:
  • Importer: GOLDEN WELL INTERNATIONAL INC
  • Address: 6123 190 STREET SUITE 523 ; Fresh Meadows, NY 11365 UNITED STATES
• Importing Logistics Registration:
  • Importer: Kareway Product, Inc.
  • Address: 2550 S. Dominguez Hills Dr. ; Compton, CA 90220 UNITED STATES
  • Phone: 1 310 5320009
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: Building 15, Building 12 (west), No. 1692 Xinghu Avenue Nantong Economy & Technology Development Zone; NANTONG Jiangsu, 226010 CN
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
QKO NANTONG EGENS BIOTECHNOLOGY CO.,LTD.	EGENS COVID-19 IgG/IgM Rapid Test	2020-03-27
PMN K152643 | LDJ NANTONG EGENS BIOTECHNOLOGY CO.,LTD.	EGENS Urine Test Marijuana (THC) EGENS Urine Test MDMA	2015-11-03
PMN K152643 | LAF NANTONG EGENS BIOTECHNOLOGY CO.,LTD.	EGENS Urine Test Marijuana (THC) EGENS Urine Test MDMA	2015-11-03
PMN K151557 | LAF NANTONG EGENS BIOTECHNOLOGY CO.,LTD.	EGENS Urine Test Cup Morphine ? Methamphetamine EGENS Urine Test DipCard Morphine ? Methamphetamine	2015-11-03
PMN K151557 | DNK NANTONG EGENS BIOTECHNOLOGY CO.,LTD.	EGENS Urine Test Cup Morphine ? Methamphetamine EGENS Urine Test DipCard Morphine ? Methamphetamine	2015-11-03
PMN K123050 | LCX NANTONG EGENS BIOTECHNOLOGY CO.,LTD.	EGENS One Step HCG Urine Pregnancy Test Kit (Strip, Cassette, Midstream)	2013-02-18
PMN K123050 | JHI NANTONG EGENS BIOTECHNOLOGY CO.,LTD.	EGENS One Step HCG Urine Pregnancy Test Kit (Strip, Cassette, Midstream)	2013-02-18
NGE NANTONG EGENS BIOTECHNOLOGY CO.,LTD.	EGENS Ovulation (LH) Test (strip, cassette, midstream)	2012-12-03

U.S. Import Records [external site]

Import ID	Shipment	Cargo Description	Quantity
2020092619870	Shanghai ,China (Mainland) -> Savannah, Georgia	HCG PREGNANCY TEST	1709 CTN
2020062238346	Shanghai ,China (Mainland) -> Tacoma, Washington	HCG PRENGNANCY TEST LH OVULATION TEST	5509 CTN
2019120772168	Shanghai ,China (Mainland) -> Tacoma, Washington	HCG PREGNANCY TEST HCG PREGNANCY TEST LH OVULATION TEST	5465 CTN
2019111648192	Shanghai ,China (Mainland) -> Tacoma, Washington	HCG PREGNANCY TEST LH OVULATION TEST HCG PREGNANCY TEST LH OVULATION TEST	5400 CTN
2019103120920	Ningpo ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	HCG PREGNANCY TEST	1916 CTN
2019071053971	Shanghai ,China (Mainland) -> Tacoma, Washington	MIDSTREAM EARLY MIDSTREAM EARLY PREGNANCY TEST ONE STEP PREGNANCY TEST KIT OVULATION PREDICTOR TEST KIT	5719 CTN
2019070944333	Shanghai ,China (Mainland) -> Tacoma, Washington	MIDSTREAM EARLY MIDSTREAM EARLY PREGNANCY TEST ONE STEP PREGNANCY TEST KIT OVULATION PREDICTOR TEST KIT	5719 CTN
2019062913791	Ningpo ,China (Mainland) -> New York/Newark Area, Newark, New Jersey	HCG PREGNANCY TEST	1500 CTN