Zhejiang Orient Gene Biotech Co., Ltd

Certificate CR-04-1249-875-25

Rev. 01Issued

Valid until: Apr 17, 2030

Certificate CR-04-1249-875-25 is a valid Technical documentation 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-04-1249-875-25
Certificate type: Technical documentation
Certificate status: Issued
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Version: 1
Certificate ID: 0537CR-04-1249-875-2501

Validity

Issued: Apr 17, 2025
Valid from: Apr 17, 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

Rapid Flu A&B+RSV+Adeno Antigen TestIVDR Class C
69509960GCFRA-T525aDRH3A

Linked SSCPs

SSCP CEDR-SSP-OG009

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

Rapid Flu A&B+RSV+Adeno Antigen Test
IVDR Class C
69509960GCFRA-T525aDRH3A

Documents

LanguagesEN