Ovy GmbH

Certificate Z-22-116-S-IX

Rev. N1Issued

Valid until: Apr 2, 2027

Certificate Z-22-116-S-IX is a valid Quality management system issued to Ovy GmbH and registered in EUDAMED. Valid until April 2, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: Z-22-116-S-IX
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0633Z-22-116-S-IXN1

Validity

Issued: Dec 18, 2025
Valid from: Dec 18, 2025
Valid until: Apr 2, 2027

Manufacturer

Manufacturer: Ovy GmbH
Manufacturer SRN: DE-MF-000007931
Manufacturer country: Germany

Notified body

Notified body
Notified body SRN: 0633
Notified body country: Germany

Covered devices

Ovy AppClass IIb
426059896001DT

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb1

1 scope

DEVICE
Class IIb

Documents

LanguagesDEEN