EUDAMED update: Jan 16, 2025

Hangzhou Tongzhou Biotechnology Co., Ltd.

CN-MF-000038774

Active35 devices

Address: Room 102, Building 4, No. 191, Xintian Road, Yunhe Street, 311103 Linping District, Hangzhou
Role: Manufacturer
Date of registration: Nov 21, 2023
Country: China

Hangzhou Tongzhou Biotechnology Co., Ltd. is a medical device manufacturer registered in EUDAMED. The company has 35 devices on the EU market across 32 countries. It holds 1 valid CE certificate. Headquartered in Linping District, Hangzhou, China. Explore the regulatory profile, devices and certificates on MD Atlas.

About Hangzhou Tongzhou Biotechnology Co., Ltd.

: CN-MF-000038774
Role: Manufacturer
Country: China
Organization name: Hangzhou Tongzhou Biotechnology Co., Ltd.
EU VAT number: Not applicable
Trade register: 91330101MA28U1T68N
Date of registration: Nov 21, 2023

Contact details for Hangzhou Tongzhou Biotechnology Co., Ltd.

Email: tongzhou01@tongzhoubio.com
Address: ROOM 102, BUILDING 4, NO. 191, XINTIAN ROAD, YUNHE STREET 311103 LINPING DISTRICT, HANGZHOU CHINA

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Competent authority

Name: Agencia Española de Medicamentos y Productos Sanitarios

Phone: +34 (91) 822 5274
Email: sgps@aemps.es

Officers and regulatory representatives of Hangzhou Tongzhou Biotechnology Co., Ltd.

CHEN Yani
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Connected operators

Importers

3 EU importers place this manufacturer's devices

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test	Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test	`I171-5055`	`D-I171-5055ZK`	1	On the market
Amphetamine (AMP) Rapid Test	Amphetamine (AMP) Rapid Test	`D002-1001`	`06975156256813`	1	On the market
Bacterial Diarrhea (Shigella/Salmonella/C.diff) Rapid Test	Bacterial Diarrhea (Shigella/Salmonella/C.diff) Rapid Test	`I184-6075`	`D-I184-60753T`	1	On the market
Benzodiazepines (BZO) Rapid Test	Benzodiazepines (BZO) Rapid Test	`D005-1001`	`06975156256851`	1	On the market
Buprenorphine (BUP) Rapid Test	Buprenorphine (BUP) Rapid Test	`D004-1001`	`06975156256882`	1	On the market
Chikungunya and Dengue Combo Rapid Test	Chikungunya and Dengue Combo Rapid Test	`I202-4035`	`D-I202-4035WF`	1	On the market
Cocaine (COC) Rapid Test	Cocaine (COC) Rapid Test	`D006-1001`	`06975156256806`	1	On the market
Ecstasy (MDMA) Rapid Test	Ecstasy (MDMA) Rapid Test	`D012-1001`	`06975156256820`	1	On the market
Ethyl Glucuronide (ETG) Rapid Test	Ethyl Glucuronide (ETG) Rapid Test	`D009-1001`	`06975156256875`	1	On the market
Fentanyl (FYL) Rapid Test	Fentanyl (FYL) Rapid Test	`D010-1001`	`06975156256905`	1	On the market
H.Pylori Antibody Rapid Test	H.Pylori Antibody Rapid Test	`I021-N4002T-40`	`06975156250811`	40	On the market
H.Pylori Antibody Rapid Test	H.Pylori Antibody Rapid Test	`I021-N4002-40`	`06975156250910`	40	On the market
H.Pylori Antibody Rapid Test	H.Pylori Antibody Rapid Test	`I021-N4002T-25`	`06975156250804`	25	On the market
H.Pylori Antibody Rapid Test	H.Pylori Antibody Rapid Test	`I021-N4002-25`	`06975156250903`	25	On the market
HPV Antigen Rapid Test	HPV Antigen Rapid Test	`T018-5002`	`D-T018-50027Y`	1	On the market
Human Bocavirus Antigen Rapid Test	Human Bocavirus Antigen Rapid Test	`I200-5002`	`D-I200-5002VD`	1	On the market
Kratom(KRA) Rapid Test	Kratom(KRA) Rapid Test	`D034-1001`	`06975156256868`	1	On the market
Marijuana (THC) Rapid Test	Marijuana (THC) Rapid Test	`D022-1001`	`06975156256844`	1	On the market
Methadone (MTD) Rapid Test	Methadone (MTD) Rapid Test	`D016-1001`	`06975156256899`	1	On the market
Multi-Drug Rapid Test Cup (Oral Fluid)	Multi-Drug Rapid Test Cup (Oral Fluid)	`D000-8077`	`D-D000-8077S8`	1	On the market
Multi-Drugs Rapid Test	Multi-Drugs Rapid Test	`D000-1064`	`06975156256790`	1	On the market
Nitazene (NTZ) Rapid Test(Urine)	Nitazene (NTZ) Rapid Test(Urine)	`D083-1001`	`06975156256912`	1	On the market
Opiates (OPI) Rapid Test	Opiates (OPI) Rapid Test	`D017-1001`	`06975156256837`	1	On the market
Pregnancy (hCG) Rapid Test	Pregnancy (hCG) Rapid Test	`F001-1002`	`D-F001-1002RK`	1	On the market
Pregnancy (hCG) Rapid Test	Pregnancy (hCG) Rapid Test	`F001-U1001`	`D-F001-U1011MQ`	1	On the market

Product	Trade name	Reference / catalog number	Primary DI The Primary DI is the main UDI-DI a manufacturer designates as the principal identifier for a device in EUDAMED. View in glossary →	Quantity	Status
Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test	Adenovirus/RSV/HMPV/Influenza A+B Combo Rapid Test	`I171-5055`	`D-I171-5055ZK`	1	On the market
Amphetamine (AMP) Rapid Test	Amphetamine (AMP) Rapid Test	`D002-1001`	`06975156256813`	1	On the market
Bacterial Diarrhea (Shigella/Salmonella/C.diff) Rapid Test	Bacterial Diarrhea (Shigella/Salmonella/C.diff) Rapid Test	`I184-6075`	`D-I184-60753T`	1	On the market
Benzodiazepines (BZO) Rapid Test	Benzodiazepines (BZO) Rapid Test	`D005-1001`	`06975156256851`	1	On the market
Buprenorphine (BUP) Rapid Test	Buprenorphine (BUP) Rapid Test	`D004-1001`	`06975156256882`	1	On the market
Chikungunya and Dengue Combo Rapid Test	Chikungunya and Dengue Combo Rapid Test	`I202-4035`	`D-I202-4035WF`	1	On the market
Cocaine (COC) Rapid Test	Cocaine (COC) Rapid Test	`D006-1001`	`06975156256806`	1	On the market
Ecstasy (MDMA) Rapid Test	Ecstasy (MDMA) Rapid Test	`D012-1001`	`06975156256820`	1	On the market
Ethyl Glucuronide (ETG) Rapid Test	Ethyl Glucuronide (ETG) Rapid Test	`D009-1001`	`06975156256875`	1	On the market
Fentanyl (FYL) Rapid Test	Fentanyl (FYL) Rapid Test	`D010-1001`	`06975156256905`	1	On the market
H.Pylori Antibody Rapid Test	H.Pylori Antibody Rapid Test	`I021-N4002T-40`	`06975156250811`	40	On the market
H.Pylori Antibody Rapid Test	H.Pylori Antibody Rapid Test	`I021-N4002-40`	`06975156250910`	40	On the market
H.Pylori Antibody Rapid Test	H.Pylori Antibody Rapid Test	`I021-N4002T-25`	`06975156250804`	25	On the market
H.Pylori Antibody Rapid Test	H.Pylori Antibody Rapid Test	`I021-N4002-25`	`06975156250903`	25	On the market
HPV Antigen Rapid Test	HPV Antigen Rapid Test	`T018-5002`	`D-T018-50027Y`	1	On the market
Human Bocavirus Antigen Rapid Test	Human Bocavirus Antigen Rapid Test	`I200-5002`	`D-I200-5002VD`	1	On the market
Kratom(KRA) Rapid Test	Kratom(KRA) Rapid Test	`D034-1001`	`06975156256868`	1	On the market
Marijuana (THC) Rapid Test	Marijuana (THC) Rapid Test	`D022-1001`	`06975156256844`	1	On the market
Methadone (MTD) Rapid Test	Methadone (MTD) Rapid Test	`D016-1001`	`06975156256899`	1	On the market
Multi-Drug Rapid Test Cup (Oral Fluid)	Multi-Drug Rapid Test Cup (Oral Fluid)	`D000-8077`	`D-D000-8077S8`	1	On the market
Multi-Drugs Rapid Test	Multi-Drugs Rapid Test	`D000-1064`	`06975156256790`	1	On the market
Nitazene (NTZ) Rapid Test(Urine)	Nitazene (NTZ) Rapid Test(Urine)	`D083-1001`	`06975156256912`	1	On the market
Opiates (OPI) Rapid Test	Opiates (OPI) Rapid Test	`D017-1001`	`06975156256837`	1	On the market
Pregnancy (hCG) Rapid Test	Pregnancy (hCG) Rapid Test	`F001-1002`	`D-F001-1002RK`	1	On the market
Pregnancy (hCG) Rapid Test	Pregnancy (hCG) Rapid Test	`F001-U1001`	`D-F001-U1011MQ`	1	On the market

Hangzhou Tongzhou Biotechnology Co., Ltd.

About Hangzhou Tongzhou Biotechnology Co., Ltd.

Contact details for Hangzhou Tongzhou Biotechnology Co., Ltd.

Export the 35 devices of Hangzhou Tongzhou Biotechnology Co., Ltd.

Competent authority

Officers and regulatory representatives of Hangzhou Tongzhou Biotechnology Co., Ltd.

Connected operators

Importers

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About Hangzhou Tongzhou Biotechnology Co., Ltd.

Contact details for Hangzhou Tongzhou Biotechnology Co., Ltd.

Export the 35 devices of Hangzhou Tongzhou Biotechnology Co., Ltd.

Competent authority

Officers and regulatory representatives of Hangzhou Tongzhou Biotechnology Co., Ltd.

Statistics for Hangzhou Tongzhou Biotechnology Co., Ltd.

Certificate health for Hangzhou Tongzhou Biotechnology Co., Ltd.

Related documents

Devices by risk class

Market presence of Hangzhou Tongzhou Biotechnology Co., Ltd.

Device catalog for Hangzhou Tongzhou Biotechnology Co., Ltd.

Device families (Basic UDI-DI) of Hangzhou Tongzhou Biotechnology Co., Ltd.

Connected operators

Importers

Related searches

Market presence of Hangzhou Tongzhou Biotechnology Co., Ltd.

Devices by risk class

Device families (Basic UDI-DI) of Hangzhou Tongzhou Biotechnology Co., Ltd.

Related documents

Statistics for Hangzhou Tongzhou Biotechnology Co., Ltd.

Certificate health for Hangzhou Tongzhou Biotechnology Co., Ltd.

Device catalog for Hangzhou Tongzhou Biotechnology Co., Ltd.