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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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Dompé farmaceutici s.p.a.

Certificate ITD 1343612 1

Rev. 2.0Supplemented
Valid until
Oct 22, 2029

Certificate ITD 1343612 1 is a valid Quality assurance issued to Dompé farmaceutici s.p.a. and registered in EUDAMED. Valid until October 22, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number
ITD 1343612 1
Certificate type
Quality assurance
Certificate status
Supplemented
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
3
Certificate ID
1936ITD 1343612 12.0

Validity

Issued
Sep 16, 2025
Valid from
Sep 16, 2025
Valid until
Oct 22, 2029

Notified body

Notified body
TUV Rheinland Italia SRL
Notified body SRN
1936
Notified body country
Italy

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
No
Mechanism of scrutiny
No
Intended medical purpose
No
SPP applicable
No
Conditions applicable
No
MOS outside EUDAMED
No
QMS/MOS type
Others

History

Status changes

  • Supplemented

Supersedes

  • ITD 1343612 1Quality assuranceSupplementedOct 23, 2024 → Oct 22, 2029

Scope coverage

Class I1

1 scope

  • Dispositivi non impiantabili non attivi per oftalmologia / Non-active non-implantable ophthalmologic devices
    Class I

Manufacturer

Manufacturer
Dompé farmaceutici s.p.a.
Manufacturer SRN
IT-MF-000016097
Manufacturer country
Italy

Documents

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