Assure Tech. (Hangzhou) Co., Ltd.

Certificate IX 2074650-1

Rev. Rev.1Issued

Valid until: Jun 12, 2029

Certificate IX 2074650-1 is a valid Technical documentation 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: IX 2074650-1
Certificate type: Technical documentation
Certificate status: Issued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 0197IX 2074650-1Rev.1

Validity

Issued: Dec 27, 2024
Valid from: Dec 27, 2024
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

Strep A Rapid TestIVDR Class B
69528048A463101ZT

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class B1

1 scope

Strep A Rapid Test
IVDR Class B
69528048A463101ZT

Documents

LanguagesEN