GO-Pen ApS

Certificate MDR-0033

Rev. 2Amended

Valid until: Oct 26, 2030

Certificate MDR-0033 is a valid Quality management system issued to GO-Pen ApS and registered in EUDAMED. Valid until October 26, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR-0033
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1304MDR-00332

Validity

Issued: Apr 9, 2026
Valid from: Apr 9, 2026
Valid until: Oct 26, 2030

Notified body

Notified body: SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
Notified body SRN: 1304
Notified body country: Slovenia

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: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Class IIb only

History

Status changes

Amended

Supersedes

MDR-0033Quality management systemIssuedOct 27, 2025 → Oct 26, 2030

Scope coverage

Class IIb2

2 scopes

Cartridge syringes
Class IIb
GO_PEN®
Class IIb

Documents

LanguagesEN