EUDAMED update: Mar 31, 2026

Hangzhou Alltest Biotech.Co.,Ltd.

CN-MF-000010710

2,046 devices

Address: Yinhai Street, #550 310018 Hangzhou
Role: Manufacturer
Date of registration: Jul 28, 2021
Country: China

Hangzhou Alltest Biotech.Co.,Ltd. is a medical device manufacturer registered in EUDAMED. The company has 2,046 devices on the EU market across 32 countries. It holds 6 valid CE certificates. Headquartered in Hangzhou, China. Explore the regulatory profile, devices and certificates on MD Atlas.

About Hangzhou Alltest Biotech.Co.,Ltd.

: CN-MF-000010710
Role: Manufacturer
Country: China
Organization name: Hangzhou Alltest Biotech.Co.,Ltd.
EU VAT number: 91330101685842840Y
Date of registration: Jul 28, 2021

Contact details for Hangzhou Alltest Biotech.Co.,Ltd.

Email: info@alltests.com.cn
Address: #550, YINHAI STREET HANGZHOU ECONOMIC & TECHNOLOGICAL DEVELOPMENT AREA 310018 HANGZHOU CHINA

Competent authority

Name: DE/CA22 - Bezirksregierung Münster

Phone: 0049251411-0
Email: poststelle@brms.nrw.de

Officers and regulatory representatives of Hangzhou Alltest Biotech.Co.,Ltd.

ZHANG Yan
Responsibility or Authorize Responsibility the conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released. Responsibility or Authorize Responsibility the post-market surveillance obligations and the reporting obligations are complied with the regulatory requirements
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WU Rosa
Responsibility the technical documentation and the EU declaration of conformity are drawn up and kept up-to-date; Responsibility in the case of devices for performance studies intended to be used in the context of interventional clinical performance studies or other performance studies involving risks for the subjects.
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Connected operators

Importers

90 EU importers place this manufacturer's devices

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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
16-Channel Fluorescence Immunoassay Analyzer	16-Channel Fluorescence Immunoassay Analyzer	`AFR-800`	`06936983136471`	1	On the market
Fluorescence Immunoassay Analyzer	Fluorescence Immunoassay Analyzer	`AFR-302`	`06936983117999`	1	On the market
FYL Rapid Test Cassette	FYL Rapid Test Cassette	`DFY-802`	`D-DFY-802SS`	1	On the market
H. pylori Antibody Rapid Test Cassette	H. pylori Antibody Rapid Test Cassette	`IHP-302`	`D-IHP-302SD`	1	On the market
H. pylori Antibody Rapid Test Dipstick	H. pylori Antibody Rapid Test Dipstick	`IHP-401`	`D-IHP-401SG`	1	On the market
Lateral Flow (LF) Portable Reader Plus	Lateral Flow (LF) Portable Reader Plus	`ATR-400`	`06936983131278`	1	On the market
SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test	SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test	`IRT-545`	`06936983134897`	1	On the market
"Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette"	"Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette"	`ICD-635`	`06936983126175`	1	On the market
"Combo Prueba Rápida Clostridium difficile GDH+Toxina A+Toxina B en Casete "	"Combo Prueba Rápida Clostridium difficile GDH+Toxina A+Toxina B en Casete "	`ICD-635B`	`08436592551019`	1	On the market
"Family Health Self Test Blood Feces"	"Family Health Self Test Blood Feces"	`8059015832467`	`06936983199544`	1	On the market
"Family Health Self Test Blood Feces"	"Family Health Self Test Blood Feces"	`8059015832467`	`06936983199506`	1	On the market
"Prueba Rápida Combinada de Rotavirus y Adenovirus en Casete "	"Prueba Rápida Combinada de Rotavirus y Adenovirus en Casete "	`IRAC-625`	`06936983126182`	1	On the market
"Prueba Rápida de Embarazo (hCG) de Sensibilidad mejorada en Tira "	"Prueba Rápida de Embarazo (hCG) de Sensibilidad mejorada en Tira "	`FHC-U201`	`06936983126236`	1	On the market
"Test de grossesse rapide hCG à haute sensibilité, à jet intermédiaire (urine) Test destiné à l’autodiagnostic"	"Test de grossesse rapide hCG à haute sensibilité, à jet intermédiaire (urine) Test destiné à l’autodiagnostic"	`HCG-02-WP`	`03664756003684`	1	On the market
"ZuhauseTEST Healthy Gut"	"ZuhauseTEST Healthy Gut"	`600400`	`06936983199575`	1	On the market
2019-CoV IgG/IgM Rapid Test Cassette	2019-CoV IgG/IgM Rapid Test Cassette	`INCP-402B`	`D-INCP-402B4N`	1	On the market
2019-CoV IgG/IgM Rapid Test Cassette	2019-CoV IgG/IgM Rapid Test Cassette	`INCP-402`	`D-INCP-402H8`	1	On the market
6-MAM Rapid Test	6-MAM Rapid Test	`DMA-803`	`D-DMA-803MF`	1	On the market
6-MAM Rapid Test Cassette	6-MAM Rapid Test Cassette	`DMA-H902`	`D-DMA-H9027P`	1	On the market
6-MAM Rapid Test Cassette	6-MAM Rapid Test Cassette	`DMA-R102`	`D-DMA-R1028M`	1	On the market
6-MAM Rapid Test Cassette	6-MAM Rapid Test Cassette	`DMA-802`	`D-DMA-802MD`	1	On the market
6-MAM Rapid Test Panel	6-MAM Rapid Test Panel	`DMA-114`	`D-DMA-114LH`	1	On the market
7-ACL Rapid Test Cassette	7-ACL Rapid Test Cassette	`DACL-102`	`D-DACL-1025H`	1	On the market
7-ACL Rapid Test Cassette	7-ACL Rapid Test Cassette	`DACL-R102`	`D-DACL-R102UZ`	1	On the market
7-ACL Rapid Test Dipstick	7-ACL Rapid Test Dipstick	`DACL-101`	`D-DACL-1015F`	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
16-Channel Fluorescence Immunoassay Analyzer	16-Channel Fluorescence Immunoassay Analyzer	`AFR-800`	`06936983136471`	1	On the market
Fluorescence Immunoassay Analyzer	Fluorescence Immunoassay Analyzer	`AFR-302`	`06936983117999`	1	On the market
FYL Rapid Test Cassette	FYL Rapid Test Cassette	`DFY-802`	`D-DFY-802SS`	1	On the market
H. pylori Antibody Rapid Test Cassette	H. pylori Antibody Rapid Test Cassette	`IHP-302`	`D-IHP-302SD`	1	On the market
H. pylori Antibody Rapid Test Dipstick	H. pylori Antibody Rapid Test Dipstick	`IHP-401`	`D-IHP-401SG`	1	On the market
Lateral Flow (LF) Portable Reader Plus	Lateral Flow (LF) Portable Reader Plus	`ATR-400`	`06936983131278`	1	On the market
SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test	SARS-CoV-2/Influenza A+B/RSV/Adenovirus Antigen Combo Rapid Test	`IRT-545`	`06936983134897`	1	On the market
"Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette"	"Clostridium difficile GDH+ Toxin A +Toxin B Combo Rapid Test Cassette"	`ICD-635`	`06936983126175`	1	On the market
"Combo Prueba Rápida Clostridium difficile GDH+Toxina A+Toxina B en Casete "	"Combo Prueba Rápida Clostridium difficile GDH+Toxina A+Toxina B en Casete "	`ICD-635B`	`08436592551019`	1	On the market
"Family Health Self Test Blood Feces"	"Family Health Self Test Blood Feces"	`8059015832467`	`06936983199544`	1	On the market
"Family Health Self Test Blood Feces"	"Family Health Self Test Blood Feces"	`8059015832467`	`06936983199506`	1	On the market
"Prueba Rápida Combinada de Rotavirus y Adenovirus en Casete "	"Prueba Rápida Combinada de Rotavirus y Adenovirus en Casete "	`IRAC-625`	`06936983126182`	1	On the market
"Prueba Rápida de Embarazo (hCG) de Sensibilidad mejorada en Tira "	"Prueba Rápida de Embarazo (hCG) de Sensibilidad mejorada en Tira "	`FHC-U201`	`06936983126236`	1	On the market
"Test de grossesse rapide hCG à haute sensibilité, à jet intermédiaire (urine) Test destiné à l’autodiagnostic"	"Test de grossesse rapide hCG à haute sensibilité, à jet intermédiaire (urine) Test destiné à l’autodiagnostic"	`HCG-02-WP`	`03664756003684`	1	On the market
"ZuhauseTEST Healthy Gut"	"ZuhauseTEST Healthy Gut"	`600400`	`06936983199575`	1	On the market
2019-CoV IgG/IgM Rapid Test Cassette	2019-CoV IgG/IgM Rapid Test Cassette	`INCP-402B`	`D-INCP-402B4N`	1	On the market
2019-CoV IgG/IgM Rapid Test Cassette	2019-CoV IgG/IgM Rapid Test Cassette	`INCP-402`	`D-INCP-402H8`	1	On the market
6-MAM Rapid Test	6-MAM Rapid Test	`DMA-803`	`D-DMA-803MF`	1	On the market
6-MAM Rapid Test Cassette	6-MAM Rapid Test Cassette	`DMA-H902`	`D-DMA-H9027P`	1	On the market
6-MAM Rapid Test Cassette	6-MAM Rapid Test Cassette	`DMA-R102`	`D-DMA-R1028M`	1	On the market
6-MAM Rapid Test Cassette	6-MAM Rapid Test Cassette	`DMA-802`	`D-DMA-802MD`	1	On the market
6-MAM Rapid Test Panel	6-MAM Rapid Test Panel	`DMA-114`	`D-DMA-114LH`	1	On the market
7-ACL Rapid Test Cassette	7-ACL Rapid Test Cassette	`DACL-102`	`D-DACL-1025H`	1	On the market
7-ACL Rapid Test Cassette	7-ACL Rapid Test Cassette	`DACL-R102`	`D-DACL-R102UZ`	1	On the market
7-ACL Rapid Test Dipstick	7-ACL Rapid Test Dipstick	`DACL-101`	`D-DACL-1015F`	1	On the market

Hangzhou Alltest Biotech.Co.,Ltd.

About Hangzhou Alltest Biotech.Co.,Ltd.

Contact details for Hangzhou Alltest Biotech.Co.,Ltd.

Competent authority

Officers and regulatory representatives of Hangzhou Alltest Biotech.Co.,Ltd.

Connected operators

Importers

Export the 2,046 devices of Hangzhou Alltest Biotech.Co.,Ltd.

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About Hangzhou Alltest Biotech.Co.,Ltd.

Contact details for Hangzhou Alltest Biotech.Co.,Ltd.

Competent authority

Officers and regulatory representatives of Hangzhou Alltest Biotech.Co.,Ltd.

Statistics for Hangzhou Alltest Biotech.Co.,Ltd.

Certificate health for Hangzhou Alltest Biotech.Co.,Ltd.

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Devices by risk class

Market presence of Hangzhou Alltest Biotech.Co.,Ltd.

Device catalog for Hangzhou Alltest Biotech.Co.,Ltd.

Device families (Basic UDI-DI) of Hangzhou Alltest Biotech.Co.,Ltd.

Connected operators

Importers

Export the 2,046 devices of Hangzhou Alltest Biotech.Co.,Ltd.

Related searches

Market presence of Hangzhou Alltest Biotech.Co.,Ltd.

Devices by risk class

Related documents

Statistics for Hangzhou Alltest Biotech.Co.,Ltd.

Certificate health for Hangzhou Alltest Biotech.Co.,Ltd.

Device catalog for Hangzhou Alltest Biotech.Co.,Ltd.

Device families (Basic UDI-DI) of Hangzhou Alltest Biotech.Co.,Ltd.