newbox medical GmbH

Certificate MDR-0019

Rev. 2Amended

Valid until: Oct 15, 2029

Certificate MDR-0019 is a valid Quality management system issued to newbox medical GmbH and registered in EUDAMED. Valid until October 15, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR-0019
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1304MDR-00192

Validity

Issued: Nov 24, 2025
Valid from: Nov 24, 2025
Valid until: Oct 15, 2029

Manufacturer

Manufacturer: newbox medical GmbH
Manufacturer SRN: DE-MF-000020279
Manufacturer country: Germany

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-0019Quality management systemIssuedOct 16, 2024 → Oct 15, 2029

Scope coverage

Class IIb3

3 scopes

Kirschner bone wires
Class IIb
Kirschner-wires, sterile
Class IIb
Kirschner-wires, non-sterile
Class IIb

Documents

LanguagesEN