Zhejiang Orient Gene Biotech Co., Ltd

Certificate CR-04-1249-874-25

Rev. 03Supplemented

Valid until: Apr 17, 2030

Certificate CR-04-1249-874-25 is a valid Quality management system issued to Zhejiang Orient Gene Biotech Co., Ltd and registered in EUDAMED. Valid until April 17, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: CR-04-1249-874-25
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 3
Certificate ID: 0537CR-04-1249-874-2503

Validity

Issued: Sep 22, 2025
Valid from: Sep 22, 2025
Valid until: Apr 17, 2030

Manufacturer

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0537
Notified body country: Finland

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

CR-04-1249-874-25Quality management systemSupplementedSep 5, 2025 → Apr 17, 2030

Scope coverage

IVDR Class C3

3 scopes

IVR 0503 Devices intended to be used to detect the presence of, or exposure to an infectious agent including sexually transmitted agents
IVDR Class C
Rapid Flu A&B+RSV+Adeno Antigen Test
IVDR Class C
Rapid Influenza A & B Antigen Test
IVDR Class C

Documents

LanguagesEN