13YRSNantong Egens Biotechnology Co., Ltd.
Supplier
This supplier has been verified onsite by world-leading inspection company,
SGS Group
Verified onsite by world-leading inspection company, SGS Group
2018.10.23
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Nantong Egens Biotechnology Co., Ltd. is a manufacturer of in-vitro diagnosing reagents in China. We make a contribution of 100 million one-step test strips to Chinese market each year. Strict quality control, profitable prices, strong R&D team, and good service make our products enjoy a high reputation both at home and abroad. Our products mainly go through the following tests: 1. Fertility Test: hCG, and LH 2. Infectious Disease Test: HBV (5 in 1), Anti-HCV, HBsAg, Anti-HBs, Anti-HBc, Anti-HBe, HBeAg, and Anti-HCV Membrane3. Sexually Transmitted Disease Test: Anti-HIV 1+2, and Anti-Syphilis4. Tumor Marker Test: AFP, FOB, PSA, and CEA 5. Drugs of Abuse test: Opiates/Morphine/Heroin test, and Cocaine test6. Cholinesterase (CHE) testThe above mentioned products feature high quality and sensitivity. Please contact us for more details.
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Business Type
Manufacturer, Trading Company
Country / Region
Jiangsu, China
Main ProductsOwnership
Private Owner
Total Employees
201 - 300 People
Total Annual Revenue
USD 19500000
Year Established
1999
Certifications(4)
Product Certifications(1)Patents
-
Trademarks(1)Main Markets

PRODUCT CAPACITY

Production Flow

Production Equipment

Name
No
Quantity
Verified
Auto Packing Machine(Cassette)
GEREKE
16
Auto Packing Machine(Strip)
BSD
4
Outer Packing Machine
LYPACK
6
Auto Packing Machine(Midstream)
DZB-250C
1
Filling Machine (Buffer)
Lilupack
2
Centrifugal Machine
GL-21M
2
Ruling Machine
DJ-331
2
Filming Machine
Autokun
8
Cutting Machine
N/A
16
Verified

Factory Information

Factory Size
5,000-10,000 square meters
Factory Country/Region
Building 15, No. 1692, Xinghu Avenue, Economy & Technology Development Zone, Nantong City, Jiangsu Province, China
No. of Production Lines
2
Contract Manufacturing
OEM Service Offered

Annual Production Capacity

Product Name
Production Line Capacity
Actual Units Produced(Previous Year)
Verified
Fertility & Eugenic Test, Multi-DOA, Infectious Disease, Clia & Elisa Test
20000000 pcs / Month
confidential
Verified

QUALITY CONTROL

Test Equipment

Machine Name
Brand & Model NO
Quantity
Verified
N/A
N/A
N/A
Verified

R&D CAPACITY

Production Certification

Picture
Certification Name
Certified By
Business Scope
Available Date
Verified
Other
TUV SUD
2017-08-25 ~ 2022-08-24
CE
TUV SUD
Products for determination of tumor markers(PSA) and products for self testing
2013-08-27 ~ 2017-08-24
Malaria pf
China Food and Drug Administration
Malaria pf test
2014-01-04 ~ 2018-01-13
Malaria pf/pv
China Food and Drug Administration
Malaria pf/pv test
2014-01-14 ~ 2018-01-13
MOP
China Food and Drug Administration
Diagnostic kit for Morphine(Colloidal Gold)
2012-03-14 ~ 2016-03-13
KET
China Food and Drug Administration
Diagnostic kit for Ketamine(Colloidal Gold)
2012-03-04 ~ 2016-03-03
MET
China Food and Drug Administration
Diagnostic kit for Methamphetamine(Colloidal Gold)
2012-03-14 ~ 2016-03-13
CE
TUV Rheinland
Blood glucose Monitoring System(Glucometer@ Blood glucose test strips)
2015-06-15 ~ 2020-06-14
CE
TUV Rheinland
Drug Abuse Test AMP\BAR\BZO\BUP\COC\KET\MET\MTD\MOP\MDMA\OXY\PCP\TCA\TRA\THC
2015-06-25 ~ 2020-06-24
FDA
US FDA
Test System:EGENS Urine Test Cup Morphine-Methamphetamine Analyte:Morphine Complexity:WAIVED Test System:EGENS Urine Test DipCard Morphine-Methamphetamine Analyte:Methamphetamine/amphetamine Complexity:WAIVED
2015-07-24 ~
Verified

Certification

Picture
Certification Name
Certified By
Business Scope
Available Date
Verified
OHSAS18001
Other
Design and development, production and related management activities of three class 6840 in vitro diagnosis reagents (medical device registered products)
2016-05-17 ~ 2019-05-16
ISO9001
Other
Design and development, production of three class 6840 in vitro diagnosis
2016-05-17 ~ 2019-05-16
ISO13485
TUV SUD
Design and development, production and distribution of rapid test kit for the detection of fertility function hormones, pregnancy, tumor markers, drugs of abuse, infectious disease, sperm concentration and clinical chemistry, blood glucose monitoring system
2016-09-01 ~ 2019-08-31
ISO14001
Other
Design and development, production of three class 6840 in vitro diagnosis reagents and related management activities
2018-05-24 ~ 2021-05-23
ISO14001
CNCA
Design and Development,Production of Class III 6840 in Vitro Diagnosis Reagents(Medical Device Registered Products)and Related Management Activities
2012-06-03 ~ 2015-06-02
OHSAS18001
CNCA
Design and Development,Production of Class III 6840 in Vitro Diagnosis Reagents(Medical Device Registered Products)and Related Management Activities
2013-05-26 ~ 2016-05-25
ISO9001
CNCA
Design and Development,Production,Service of Class III 6840 in Vitro Diagnosis Reagents(Medical Device Registered Products)
2013-05-26 ~ 2016-05-25
ISO13485
TUV SUD
Design and Development,Production and Distribution of Rapid Test Kit for the Detection of Fertility Function Hormones, Pregnancy, Tumor Markers,Drugs of Abuse,Infections Disease and Clinical Chemistry,Blood Glucose Monitoring System.
2013-09-01 ~ 2016-08-31
ISO13485
TUV SUD
Design and Development,Production and Distribution of Rapid Test Kit for the Detection of Fertility Function Hormones, Pregnancy, Tumor Markers,Drugs of Abuse,Infections Disease,Sperm Concentration and Clinical Chemistry,Blood Glucose Monitoring System.
2013-09-01 ~ 2016-08-31
Verified

Trademarks

Picture
Trademark No
Trademark Name
Trademark Category
Available Date
Verified
EGENS
Verified

Awards Certification

Picture
Name
Issued By
Start Date
Description
Verified
CE
TUV SUD
2013-08-27
ISO9001
CNCA
2013-05-26
ISO14001
CNCA
2012-06-03
OHSAS18001
CNCA
2013-05-26
ISO13485
TUV SUD
2013-09-01
ISO 13485 CMDCAS
TUV SUD
2013-09-01
Verified

Research & Development

11 - 20 People