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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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Dedalus Italia SpA

Certificate MDR 00290-A

Rev. 1Issued
Valid until
Nov 15, 2027

Certificate MDR 00290-A is a valid Quality management system issued to Dedalus Italia SpA and registered in EUDAMED. Valid until November 15, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number
MDR 00290-A
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
0476MDR 00290-A1

Validity

Issued
Jan 31, 2026
Valid from
Jan 31, 2026
Valid until
Nov 15, 2027

Notified body

Notified body
KIWA CERMET ITALIA S.P.A.
Notified body SRN
0476
Notified body country
Italy

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
Yes
Intended medical purpose
No
SPP applicable
No
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Basic UDI-DI data and Class IIb

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb8

8 scopes

  • V92
    Class IIb
  • V92
    Class IIb
  • V92
    Class IIb
  • V92
    Class IIb
  • DEVICE
    Class IIb
  • DEVICE
    Class IIb
  • DEVICE
    Class IIb
  • DEVICE
    Class IIb

Manufacturer

Manufacturer
Dedalus Italia SpA
Manufacturer SRN
IT-MF-000009127
Manufacturer country
Italy

Covered devices

  • P4CClass IIb
    805572803P4CK7
  • O4CClass IIb
    805572803O4CK2
  • ER4H FirstAid WebClass IIb
    805572803ER4HDK
  • FARMASAFE@Class IIb
    805572803FARMASAFEDG

Documents

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