Astron Dental

Certificate 25 0383 QR/NB

Issued

Valid until: Sep 25, 2030

Certificate 25 0383 QR/NB is a valid Quality management system issued to Astron Dental and registered in EUDAMED. Valid until September 25, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 25 0383 QR/NB
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 102325 0383 QR/NB

Validity

Issued: Sep 26, 2025
Valid from: Sep 26, 2025
Valid until: Sep 25, 2030

Manufacturer

Manufacturer: Astron Dental
Manufacturer SRN: US-MF-000034006
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 1023
Notified body country: Czechia

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
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: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

Occlusal Splint Appliance Material
Class IIa
Flexible Occlusal Splint Material
Class IIa

Documents

LanguagesEN