Is this your brand? Sign in to claim ownership.

Sign in to claim this brand

HANGZHOU CLONGENE BIOTECH CO., LTD.

China·CN-MF-000030069

Last updated September 17, 2026

Information

Country
China
Address
No. 1, Yichuang Road, Hangzhou, China
LinkedIn
—
Facebook
—
Phone
+86-571-88617879
PRRC Contact
Xuxia Ying
EUDAMED SRN
CN-MF-000030069
FDA FEI Number
3009414546
DUNS Number
—

Catalogue (16)

DeviceModel / ReferenceRegistriesClassStatus
RSV Antigen Rapid Test Cassette (Swab) IRSVn002, IRSVn008
EUDAMED
IVD GeneralActive
CLUNGENE HCG Pregnancy Rapid Test Cassette, CLUNGENE HCG Pregnancy Rapid Test Strip, CLUNGENE HCG Pregnancy Rapid Test Midstream K193132
EUDAMEDFDA 510(k)
Class IIActive
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup K181790
FDA 510(k)
Class IIActive
CLUNGENE Multi-Drug Test Easy Cup; CLUNGENE Multi-Drug Home Test Easy Cup K252118
FDA 510(k)
Class IIActive
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup K190412
FDA 510(k)
Class IIActive
CLUNGENE Amphetamine Tests, CLUNGENE Cocaine Tests, CLUNGENE Oxazepam Tests K161251
FDA 510(k)
Class IIActive
CLUNGENE Multi-Drug Test Dip Card, CLUNGENE Multi-Drug Test Easy Cup K180255
FDA 510(k)
Class IIActive
CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette K242802
FDA 510(k)
Class IIActive
Clungene RSV Antigen Rapid Test K253318
FDA 510(k)
Class IActive
CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test K153741
FDA 510(k)
Class IIActive
COVID-19 Antigen Rapid Test ISCOVu002-A001; ISCOVu002-A005; ISCOVu002-A025; ISCOVu002-B001; ISCOVu002-B005; ISCOVu002-B025
EUDAMED
IVD devices for self-testingActive
Fecal Occult Blood Rapid Test TFOB6002
EUDAMED
IVD GeneralActive
H.pylori Antigen Rapid Test Cassette (Feces) IrHPG6002
EUDAMED
IVD GeneralActive
Marijuana (THC) Rapid Test DTHC1001,STHC1002,DTHC1004
EUDAMED
IVD GeneralActive
COVID-19 Antigen Rapid Test ICOV5002-B001;ICOV5002-B005;ICOV5002-B025
EUDAMED
IVD GeneralActive
LH Ovulation Rapid Tests WSLH1001,WSLH1002,WSLH1003
EUDAMED
IVD devices for self-testingActive

Related Companies

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Establishments (1)

Establishments registered with the FDA under this company group, matched by name.

  • Hangzhou Clongene Biotech Co., Ltd. US