2nd Sight Medical Co.,Ltd.

Certificate HZ 2318510-1

Rev. 0Issued

Valid until: May 18, 2028

Certificate HZ 2318510-1 is a valid Quality management system issued to 2nd Sight Medical Co.,Ltd. and registered in EUDAMED. Valid until May 18, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2318510-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2318510-10

Validity

Issued: May 19, 2023
Valid from: May 19, 2023
Valid until: May 18, 2028

Manufacturer

Manufacturer: 2nd Sight Medical Co.,Ltd.
Manufacturer SRN: CN-MF-000014431
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: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa1

1 scope

Q020101 - OPHTHALMIC MICROKNIVES
Class IIa

Documents

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