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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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LUZZANI DENTAL SRL

Certificate IT344114

Rev. 1Issued
Valid until
Jul 15, 2030

Overview

Certificate number
IT344114
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
1370IT3441141

Validity

Issued
Jul 16, 2025
Valid from
Jul 16, 2025
Valid until
Jul 15, 2030

Manufacturer

Manufacturer
LUZZANI DENTAL SRL
Manufacturer SRN
IT-MF-000011279
Manufacturer country
Italy

Notified body

Notified body
BUREAU VERITAS ITALIA S.P.A.
Notified body SRN
1370
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 IIa4

4 scopes

  • Z12110199 - INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER
    Class IIa
  • Q019001: SALIVA ASPIRATORS AND SALIVA ABSORBENTS
    Class IIa
  • Multifunctional syringes: Minibright, Minilight, MiniMate, MiniAssistant
    Class IIa
  • Airmatic suction system: Airmatic, Airmatic NA, Airmatic S, Airmatic SNA
    Class IIa

Documents

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