Zhejiang Greylynx Biotech Co., Ltd.

Certificate IX 2566030-1

Rev. Rev.0Issued

Valid until: Mar 12, 2030

Certificate IX 2566030-1 is a valid Technical documentation issued to Zhejiang Greylynx Biotech Co., Ltd. and registered in EUDAMED. Valid until March 12, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: IX 2566030-1
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 2566030-1Rev.0

Validity

Issued: Mar 13, 2025
Valid from: Mar 13, 2025
Valid until: Mar 12, 2030

Manufacturer

Manufacturer
Manufacturer SRN: CN-MF-000032462
Manufacturer country: China

Notified body

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

Covered devices

Strep A Rapid TestIVDR Class C
697620276GISTA000014E

Linked SSCPs

SSCP TD020-SSP

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

IVDR Class C1

1 scope

Strep A Rapid Test
IVDR Class C
697620276GISTA000014E

Documents

LanguagesEN