EUDAMED update: May 29, 2026

Suzhou Precigenome Ltd, Co;

CN-MF-000024105

10 devices

Address: Sangtian Street, No.218 215000 Suzhou, Jiangsu Province
Role: Manufacturer
Date of registration: May 18, 2022
Country: China

Suzhou Precigenome Ltd, Co; is a medical device manufacturer registered in EUDAMED. The company has 10 devices on the EU market across 2 countries. Headquartered in Suzhou, Jiangsu Province, China. Explore the regulatory profile, devices and certificates on MD Atlas.

About Suzhou Precigenome Ltd, Co;

: CN-MF-000024105
Role: Manufacturer
Country: China
Organization name: Suzhou Precigenome Ltd, Co;
EU VAT number: 91320594MA1PDDMT5P
Date of registration: May 18, 2022

Contact details for Suzhou Precigenome Ltd, Co;

Phone: +86-512-67503398
Email: Jiadong@rainsurebio.com
Website: www.rainsurebio.com
Address: NO.218, SANGTIAN STREET UNIT 202, BUILDING 1, NO.218 SANGTIAN STREET, SUZHOU INDUSTRIAL PARK, SUZHOU, JIANGSU PROVINCE, CHINA 215000 SUZHOU, JIANGSU PROVINCE CHINA

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Competent authority

Name: DE/CA20, Bezirksregierung Düsseldorf Dezernat 24

Phone: -
Email: dez24.mpg@brd.nrw.de

Officers and regulatory representatives of Suzhou Precigenome Ltd, Co;

WANG Yaqi
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Connected operators

Importers

1 EU importer places 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
BCR ABL p210/p190 digital PCR one-tube quant test	BCR ABL p210/p190 digital PCR one-tube quant test	`3.02.03.0001`	`06975760470162`	1	On the market
Human JAK2 Gene V617F Mutation Detection Kit (Digital PCR Method)	Human JAK2 Gene V617F Mutation Detection Kit (Digital PCR Method)	`3.02.03.0006`	`06975760470179`	1	On the market
PCR (Polymerase Chain Reaction) Amplifying Apparatus	PCR (Polymerase Chain Reaction) Amplifying Apparatus	`L1699`	`06975760470032`	1	On the market
PIK3CA 11 Mutations Digital PCR Assay	PIK3CA 11 Mutations Digital PCR Assay	`3.02.03.0005`	`06975760470186`	1	On the market
Sepsis pathogenic microorganism detection kit (digital PCR)	Sepsis pathogenic microorganism detection kit (digital PCR)	`3.02.03.0007`	`06975760470148`	1	On the market
L1699	—	`L1699`	`06975760470049`	1	On the market
L1699	—	`L1699`	`06975760470032`	1	On the market
L1699	—	`L1699`	`06975760470124`	1	On the market
L1699	—	`L1699`	`06975760470049`	1	On the market
RS3204 , RS3205, RS3206, RS3207	—	`RS3204 , RS3205, RS3206, RS3207`	`06975760470131`	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
BCR ABL p210/p190 digital PCR one-tube quant test	BCR ABL p210/p190 digital PCR one-tube quant test	`3.02.03.0001`	`06975760470162`	1	On the market
Human JAK2 Gene V617F Mutation Detection Kit (Digital PCR Method)	Human JAK2 Gene V617F Mutation Detection Kit (Digital PCR Method)	`3.02.03.0006`	`06975760470179`	1	On the market
PCR (Polymerase Chain Reaction) Amplifying Apparatus	PCR (Polymerase Chain Reaction) Amplifying Apparatus	`L1699`	`06975760470032`	1	On the market
PIK3CA 11 Mutations Digital PCR Assay	PIK3CA 11 Mutations Digital PCR Assay	`3.02.03.0005`	`06975760470186`	1	On the market
Sepsis pathogenic microorganism detection kit (digital PCR)	Sepsis pathogenic microorganism detection kit (digital PCR)	`3.02.03.0007`	`06975760470148`	1	On the market
L1699	—	`L1699`	`06975760470049`	1	On the market
L1699	—	`L1699`	`06975760470032`	1	On the market
L1699	—	`L1699`	`06975760470124`	1	On the market
L1699	—	`L1699`	`06975760470049`	1	On the market
RS3204 , RS3205, RS3206, RS3207	—	`RS3204 , RS3205, RS3206, RS3207`	`06975760470131`	1	On the market

Suzhou Precigenome Ltd, Co;

About Suzhou Precigenome Ltd, Co;

Contact details for Suzhou Precigenome Ltd, Co;

Export the 10 devices of Suzhou Precigenome Ltd, Co;

Competent authority

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About Suzhou Precigenome Ltd, Co;

Contact details for Suzhou Precigenome Ltd, Co;

Export the 10 devices of Suzhou Precigenome Ltd, Co;

Competent authority

Officers and regulatory representatives of Suzhou Precigenome Ltd, Co;

Statistics for Suzhou Precigenome Ltd, Co;

Certificate health for Suzhou Precigenome Ltd, Co;

Devices by risk class

Market presence of Suzhou Precigenome Ltd, Co;

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Device families (Basic UDI-DI) of Suzhou Precigenome Ltd, Co;

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Importers

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Market presence of Suzhou Precigenome Ltd, Co;

Devices by risk class

Device families (Basic UDI-DI) of Suzhou Precigenome Ltd, Co;

Certificate health for Suzhou Precigenome Ltd, Co;

Statistics for Suzhou Precigenome Ltd, Co;

Device catalog for Suzhou Precigenome Ltd, Co;