phenox GmbH

Certificate 1000266807

Rev. 06Supplemented

Valid until: Dec 20, 2028

Certificate 1000266807 is a valid Quality management system issued to phenox GmbH and registered in EUDAMED. Valid until December 20, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 1000266807
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0297100026680706

Validity

Issued: Nov 20, 2025
Valid from: Nov 20, 2025
Valid until: Dec 20, 2028

Notified body

Notified body: DQS Medizinprodukte GmbH
Notified body SRN: 0297
Notified body country: Germany

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: Basic UDI-DI data only

History

Status changes

Supplemented

Supersedes

1000236360SupplementedAug 27, 2025 → Dec 19, 2028

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class III7Class I2

9 scopes

MDN 1203 - Non-active non-implantable guide catheters, balloon catheters, guidewires, introducers, filters, and related tools
Class I
MDN 1101/B - Non-active neurovascular implants
Class III
MDN 1208 - Non-active non-implantable instruments
Class III
MDN 1101/B - Non-active neurovascular implants
Class III
DEVICE
Class I
DEVICE
Class III
DEVICE
Class III
DEVICE
Class III
DEVICE
Class III