Bioplax Italia Srl

Certificate 219/MDR

Rev. 1Issued

Valid until: Sep 17, 2030

Certificate 219/MDR is a valid Quality management system issued to Bioplax Italia Srl and registered in EUDAMED. Valid until September 17, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 219/MDR
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0051219/MDR1

Validity

Issued: Sep 18, 2025
Valid from: Sep 18, 2025
Valid until: Sep 17, 2030

Notified body

Notified body: IMQ ISTITUTO ITALIANO DEL MARCHIO DI QUALITÀ S.P.A.
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: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa1

1 scope

Dispositivi medici a base di acido ialuronico destinati al trattamento di patologie orali / Medical devices based on hyaluronic acid intended for the treatment of oral pathologies
Class IIa