Unomedical A/S

Certificate 39124

Rev. 14Supplemented

Valid until: Aug 30, 2027

Certificate 39124 is a valid Quality management system issued to Unomedical A/S and registered in EUDAMED. Valid until August 30, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 39124
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 04593912414

Validity

Issued: Jun 19, 2026
Valid from: Jun 19, 2026
Valid until: Aug 30, 2027

Manufacturer

Manufacturer: Unomedical A/S
Manufacturer SRN: DK-MF-000002447
Manufacturer country: Denmark

Notified body

Notified body
Notified body SRN: 0459
Notified body country: France

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: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

39124SupplementedFeb 19, 2026 → Aug 30, 2027

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb1

1 scope

Sets de perfusion (canule rigide ou souple, pour insertion en biais ou droite) pour applications thérapeutiques sous cutanées. Infusion sets (rigid and soft cannula, angled and straight insertion) for subcutaneous therapy applications.
Class IIb

Documents

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