Orodent srl

Certificate 190/MDR

Rev. 2Supplemented

Valid until: Dec 11, 2029

Certificate 190/MDR is a valid Quality assurance issued to Orodent srl and registered in EUDAMED. Valid until December 11, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 190/MDR
Certificate type: Quality assurance
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0051190/MDR2

Validity

Issued: Jun 15, 2026
Valid from: Jun 15, 2026
Valid until: Dec 11, 2029

Manufacturer

Manufacturer: Orodent srl
Manufacturer SRN: IT-MF-000030463
Manufacturer country: Italy

Notified body

Notified body
Notified body SRN: 0051
Notified body country: Italy

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

Status changes

Supplemented

Supersedes

190/MDRIssuedDec 12, 2024 → Dec 11, 2029

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa1

1 scope

Dischi in zirconia e relativi coloranti per uso odontoiatrico / Zirconia discs and related colouring agents for dental use
Class IIa

Documents

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