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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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Schwabe Pharma Italia

Certificate ITD 1342965 1

Rev. 3.0Amended
Valid until
Apr 9, 2028

Overview

Certificate number
ITD 1342965 1
Certificate type
Quality assurance
Certificate status
Amended
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
5
Certificate ID
1936ITD 1342965 13.0

Validity

Issued
Mar 2, 2026
Valid from
Mar 2, 2026
Valid until
Apr 9, 2028

Manufacturer

Manufacturer
Schwabe Pharma Italia
Manufacturer SRN
IT-MF-000029129
Manufacturer country
Italy

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
No
Human tissues
No
Animal tissues
No
In vitro diagnostics
No
Initial registration
No
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
No
QMS/MOS type
Others

History

Status changes

  • Amended

Supersedes

  • ITD 1342965 1Quality assuranceAmendedFeb 11, 2025 → Apr 9, 2028

Scope coverage

Class IIa1

1 scope

  • Dispositivi non impiantabili non attivi costituiti da sostanze destinate a essere introdotte nel corpo umano attraverso un orifizio del corpo o per via cutanea / Non-active non-implantable devices composed of substances to be introduced into the human body via a body orifice or the dermal route
    Class IIa

Documents

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