Assure Tech. (Hangzhou) Co., Ltd.
China CN-MF-000002170 Last updated 25 Oct 2026 Part of Assure Tech. (Hangzhou) Co., Ltd.
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- Devices
- 292
- Registries
- EUDAMEDFDA
- FDA recalls
- 0
Catalogue
Tramadol Rapid Test Ref TML-U11
Fastep Male Fertility (SP-10) Home Test Ref A06610H22
DOA Cup Reader Ref ADT200，ADT201
FLU A/FLU B/RSV/ADV/MP/COVID-19 Combo Test Ref MI-S46001
Total Cholesterol Test Strips Ref C906005
AcuteckTM Blood Glucose Monitoring System Ref GOP-101ProSK
Multi-drug Urine Test Panel Ref MD-U5160
AcuteckTMBlood Glucose Test Meter Ref GOH-201
cTnI Chemiluminescence Immunoassay Test Kit Ref G100A08X
Human Chorionic Gonadotropin Rapid Test (10mIU) Ref A00010125
Multi-drug Urine Test Cup Ref MD-U610-AMP/MET/THC/MOP/COC/BZO/SOMA/PCP/MTD/MDMA
Total Cholesterol Test Strips Ref C906005
Rotavirus-Adenovirus-Astrovirus-Norovirus Combo test Ref AT-MI-F44001
Norovirus GI+GII Rapid Test Ref AT-NOV-F23
Lysergic acid diethylamide Rapid Test Ref LSD-U11
Chlamydia Rapid Test Device Ref A40110120
Strep A Rapid Test Device Ref A4631021
Human Chorionic Gonadotropin Rapid Test (25mIU) Ref A00210125
Metodesnitazene Rapid Test Ref MZN-U23
Ecotest Male Fertility (SP-10) Home Test Ref A06610H12
Multi-drug Urine Test Cup Ref MD-U6155
Blood β-Ketone Test Strips Ref C904005
Tuberculosis Antibody Rapid Test Device Ref A43910125
Human Chorionic Gonadotropin Rapid Test (20mIU) Ref A00110125
AcuteckTM Blood Glucose Test Strips Ref C902005-05
hs-CRP FIA Ref hs-CRP-W23F3
Human Luteinizing Hormone Rapid Test (30mIU) Ref A01110125
Blood Glucose Test Strips Ref C902005
Hemoglobin Test Strips Ref C905005
Dengue NS1 Ag Rapid Test Ref A4291011
COVID-19 & Influenza A/B & RSV Antigen Combo Rapid Test Ref AT-MI-S44002
Ecotest Male Fertility (SP-10) Home Test Ref A06610H11
AcuteckTM Blood Glucose Control Solution Ref C901095
Urinalysis Reagent Strip Ref URS-10T
Urinalysis Reagent Strip Ref URS-11T
HEV IgM Rapid Test Device Ref A4C410125
Interleukin-6 FIA Ref IL-6-W23F3
Handheld Fluorescence Immunoassay Analyzer Ref AFI100
AcuteckTM Blood Glucose Test Strips Ref C901005-100
S. Typhi/S. Paratyphi Antigen Combo Test Ref A4B370125
Etomidate Rapid Test Ref ETO-U11
Typhoid IgG/IgM Rapid Test Ref A43871225
H-FABP Rapid Test Device Ref A10810125
Showing 1-50 of 292
EUDAMED certificates
TÜV Rheinland LGA Products GmbH 0197 5 certificates
- IX 2074650-2 Issued
Technical documentation EU IVDR
- Issued
- 17 Mar 2026
- Expires
- 16 Mar 2031
- IX 2074650-3 Issued
Technical documentation EU IVDR
- Issued
- 17 Mar 2026
- Expires
- 16 Mar 2031
- IX 2074650-4 Issued
Technical documentation EU IVDR
- Issued
- 17 Mar 2026
- Expires
- 16 Mar 2031
- HX 2074650-1 Supplemented
Quality management system EU IVDR
- Issued
- 17 Mar 2026
- Expires
- 12 Jun 2029
- Reason
- Add device or group
- IX 2074650-1 Issued
Technical documentation EU IVDR
- Issued
- 27 Dec 2024
- Expires
- 12 Jun 2029
Notified body 0344 1 certificate
- 2279233CE01 Supplemented
Quality management system EU IVDR
- Issued
- 10 Sep 2024
- Expires
- 1 Sep 2029
- Reason
- Add device or group
Related companies
Notified bodies
- TÜV Rheinland LGA Products GmbH 0197
- Notified body 0344
FDA establishments
- Assure Tech. (Hangzhou) Co., Ltd. Hangzhou Zhejiang · CN FEI 3038560224
Information
- Country
- China
- Address
- Moganshan Road, Gongshu District, Building 4, No. 1418-50, Hangzhou, Zhejiang, China
- Website
- www.diareagent.com
- [email protected]
- Phone
- +(86)571-81022698
- PRRC contact
- Allen Chen
- EUDAMED SRN
- CN-MF-000002170
- DUNS number
- 530757741