Assure Tech. (Hangzhou) Co., Ltd.

Certificate HX 2074650-1

Rev. Rev.2Supplemented

Valid until: Jun 12, 2029

Certificate HX 2074650-1 is a valid Quality management system issued to Assure Tech. (Hangzhou) Co., Ltd. and registered in EUDAMED. Valid until June 12, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HX 2074650-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 4
Certificate ID: 0197HX 2074650-1Rev.2

Validity

Issued: Mar 17, 2026
Valid from: Mar 17, 2026
Valid until: Jun 12, 2029

Manufacturer

Manufacturer: Assure Tech. (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000002170
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: —
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: —
SPP applicable

History

Status changes

Supplemented

Supersedes

HX 2074650-1Quality management systemAmendedDec 27, 2024 → Jun 12, 2029

Scope coverage

IVDR Class B2IVDR Class C2

4 scopes

Products of Class B and Class B near-patient testing: INFECTIOUS DISEASES IVR 0503: Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents W01050901 - BACTERIOLOGY - RT & POC
IVDR Class B
Products of Class B self-testing: IMMUNOCHEMISTRY (IMMUNOLOGY) IVR 0607: Devices intended to be used for detection of pregnancy or fertility testing W01021603 - FERTILITY / PREGNANCY RT & POC
IVDR Class B
Products of Class C, self-testing and near-patient testing: CHEMISTRY / IMMUNOCHEMISTRY INSTRUMENTS IVR 0602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W02010601 - DIABETES MONITORING
IVDR Class C
Products of Class C, self-testing and near-patient testing: CLINICAL CHEMISTRY IVR 0602: Devices intended to be used for screening, determination or monitoring of physiological markers for a specific disease W01010601 - BLOOD TEST STRIPS (CC) - RT & POC
IVDR Class C

Documents

LanguagesEN