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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Assure Tech. (Hangzhou) Co., Ltd. — Manufacturer in China

EUDAMED update: Oct 30, 2023

AT

Assure Tech. (Hangzhou) Co., Ltd.

China

All roles followed

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Sources: EUDAMED

Legal information of Assure Tech. (Hangzhou) Co., Ltd.

Legal name: Assure Tech. (Hangzhou) Co., Ltd.
EU VAT number: 913301066767726252
SRN (displayed role): CN-MF-000002170
EUDAMED status: Active· registered in 2021
Registered office: Building 4, No. 1418-50, Moganshan Road, Gongshu District 310011 Hangzhou, Zhejiang, China

Contact details for Assure Tech. (Hangzhou) Co., Ltd.

Phone: +(86)571-81022698
Email: contact@diareagent.com
Website: www.diareagent.com
Address: MOGANSHAN ROAD, GONGSHU DISTRICT, BUILDING 4, NO. 1418-50 310011 HANGZHOU, ZHEJIANG CHINA

Data export

Export the 414 devices of Assure Tech. (Hangzhou) Co., Ltd.

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Medical device manufacturers in EUDAMED

Certificates of Assure Tech. (Hangzhou) Co., Ltd.

Competent authority for Assure Tech. (Hangzhou) Co., Ltd.

Ministerie van Volksgezondheid, Welzijn en Sport
NetherlandsContact the authority →

414Total Devices

388Basic UDI-DIs

6Certificates6 valid · 0 expiring < 12 months

32CountriesEU/EEA placements

Market presence of Assure Tech. (Hangzhou) Co., Ltd.

Devices placed in 32 countries

Risk categories of Assure Tech. (Hangzhou) Co., Ltd.

Executives & regulatory representatives of Assure Tech. (Hangzhou) Co., Ltd.

2 contacts identified

PRRC
CHEN Allen
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Related documents of Assure Tech. (Hangzhou) Co., Ltd.

Quality management system

Certificate 2279233CE01Rev. 06

Supplemented

Manufacturer

Assure Tech. (Hangzhou) Co., Ltd.

Notified body

DEKRA Certification B.V.

0344

Version

1

Valid from

9/10/2024

Valid until

9/1/2029

Technical documentation

Certificate IX 2074650-3Rev. Rev.0

Issued

Manufacturer

Assure Tech. (Hangzhou) Co., Ltd.

Notified body

TÜV Rheinland LGA Products GmbH

0197

Version

1

Valid from

3/17/2026

Valid until

3/16/2031

Technical documentation

Certificate IX 2074650-2Rev. Rev.0

Issued

Manufacturer

Assure Tech. (Hangzhou) Co., Ltd.

Notified body

TÜV Rheinland LGA Products GmbH

0197

Version

1

Valid from

3/17/2026

Valid until

3/16/2031

Technical documentation

Certificate IX 2074650-4Rev. Rev.0

Issued

Manufacturer

Assure Tech. (Hangzhou) Co., Ltd.

Notified body

TÜV Rheinland LGA Products GmbH

0197

Version

1

Valid from

3/17/2026

Valid until

3/16/2031

Quality management system

Certificate HX 2074650-1Rev. Rev.2

Supplemented

Manufacturer

Assure Tech. (Hangzhou) Co., Ltd.

Notified body

TÜV Rheinland LGA Products GmbH

0197

Version

4

Valid from

3/17/2026

Valid until

6/12/2029

Technical documentation

Certificate IX 2074650-1Rev. Rev.1

Issued

Manufacturer

Assure Tech. (Hangzhou) Co., Ltd.

Notified body

TÜV Rheinland LGA Products GmbH

0197

Version

1

Valid from

12/27/2024

Valid until

6/12/2029

Cartography of Assure Tech. (Hangzhou) Co., Ltd.

Authorised representativeNotified bodiesPeople

TÜV Rheinland LGA Products GmbH — 5 certificates — Assure Tech. (Hangzhou) Co., Ltd.
DEKRA Certification B.V. — 1 certificate — Assure Tech. (Hangzhou) Co., Ltd.
Lotus NL B.V. — represents — Assure Tech. (Hangzhou) Co., Ltd.
CMC Medical Devices & Drugs SL — represents — Assure Tech. (Hangzhou) Co., Ltd.
Medunion S.L. — represents — Assure Tech. (Hangzhou) Co., Ltd.
CHEN Allen — Assure Tech. (Hangzhou) Co., Ltd.

Catalog of Assure Tech. (Hangzhou) Co., Ltd.

414 devices · 390 families

Filter

Tuberculosis Rapid TestDevice1 version
HIV Rapid Test Device (Whole blood/Serum/Plasma)Device1 version
Cardiac Troponin I Rapid TestDevice1 version
Ethyl Glucuronide Rapid Test Device1 version
Legionella Urinary Antigen testDevice1 version
Streptococcus Pneumoniae TestDevice1 version
Faecal Occult Blood Hb/Hp-Complex Rapid TestDevice1 version
Zolpidem Rapid TestDevice1 version
SARS-CoV-2 Antigen Rapid Tests for Self-TestingDevice 1 person/box1 version
COVID-19 Antigen Nasal Test KitCOV-S35002H1 version
MDMA Rapid TestDevice1 version
COVID-19 & Influenza A/B Antigen Nasal Test Kit1 pcs/kit1 version
COVID-19 Antigen Rapid Test DeviceDevice 1 person/box1 version
COVID-19 Antigen Saliva Test Kitkit 3pcs/box1 version
COVID-19 Antigen Saliva Test Kitkit1 version
Free Triiodothyronine Chemiluminescence Immunoassay Test KitG015A081 version
Free Thyroid Hormone Chemiluminescence Immunoassay Test KitG016A081 version
Triiodothyronine Chemiluminescence Immunoassay Test KitG017A081 version
Thyroglobulin Chemiluminescence Immunoassay Test KitG018A081 version
Thyroid Stimulating Hormone Chemiluminescence Immunoassay Test KitG019A081 version
Thyroid Hormone Chemiluminescence Immunoassay Test KitG012A081 version
Alpha Fetoprotein Chemiluminescence Immunoassay Test KitG200A081 version
Gastrin-17 Chemiluminescence Immunoassay Test KitG210A081 version
Folate Chemiluminescence Immunoassay Test KitG702A081 version
Vitamin B12 Chemiluminescence Immunoassay Test Kit G703A081 version

390 families

Page 1 of 16

Browse all 414 products