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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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Laboratori Baldacci S.p.A.

Certificate IT339129

Rev. 1Issued
Valid until
Jan 12, 2030

Overview

Certificate number
IT339129
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
1370IT3391291

Validity

Issued
Jan 13, 2025
Valid from
Jan 13, 2025
Valid until
Jan 12, 2030

Manufacturer

Manufacturer
Laboratori Baldacci S.p.A.
Manufacturer SRN
IT-MF-000020509
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

  • NASOPHARINGEAL DEVICES – OTHER MDN 1213 - 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
  • NARLISIM SPRAY
    Class IIa
  • NARLISIM NASAL SOLUTION
    Class IIa
  • OSMONAR GEL
    Class IIa

Documents

LanguagesITEN