OneMed Group Oy

Certificate 10000510540-PA-NoMA-DNK

Rev. 4Issued

Valid until: May 18, 2027

Certificate 10000510540-PA-NoMA-DNK is a valid Quality management system issued to OneMed Group Oy and registered in EUDAMED. Valid until May 18, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 10000510540-PA-NoMA-DNK
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 246010000510540-PA-NoMA-DNK4

Validity

Issued: May 18, 2022
Valid from: May 18, 2022
Valid until: May 18, 2027

Notified body

Notified body: DNV Product Assurance AS
Notified body SRN: 2460
Notified body country: Norway

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: No
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I2

2 scopes

Sterile single use medical devices
Class I
Applicators, sterile Absorbent dressings, sterile Fixation bandages, sterile Support bandages, sterile Swabs and Sponges, gauze, sterile Swabs and Sponges, nonwoven, sterile Surgical Gowns, sterile Instrument and Equipment drapes, sterile Surgical drapes, sterile Tube holders, sterile Fluid collection pouches
Class I

Documents

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