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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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MEDI-LINE S.r.l.

Certificate CSQ000322

Rev. 00Issued
Valid until
Dec 27, 2027

Certificate CSQ000322 is a valid Quality management system issued to MEDI-LINE S.r.l. and registered in EUDAMED. Valid until December 27, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number
CSQ000322
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
0373CSQ00032200

Validity

Issued
Dec 28, 2022
Valid from
Dec 28, 2022
Valid until
Dec 27, 2027

Manufacturer

Manufacturer
MEDI-LINE S.r.l.
Manufacturer SRN
IT-MF-000019935
Manufacturer country
Italy

Notified body

Notified body
ISTITUTO SUPERIORE DI SANITA'
Notified body SRN
0373
Notified body country
Italy

Characteristics

Sterile
Yes
Human tissues
No
Animal tissues
No
In vitro diagnostics
No
Initial registration
Yes
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
—
QMS/MOS type
Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa5

5 scopes

  • DEVICE
    Class IIa
  • DEVICE
    Class IIa
  • DEVICE
    Class IIa
  • DEVICE
    Class IIa
  • DEVICE
    Class IIa

Documents

LanguagesENIT

Covered devices

  • X-ONE Trocar dilatante 3mm cannula Corta Class IIa
    805511288K01010101LW
  • X-ONE Trocar Ottico 3mm cannula CortaClass IIa
    805511288K01010103M2
  • X-ONE Kit Trocar Ottico 5mm - 2 cannule Corte Class IIa
    805511288K01010199N9
  • X-ONE Trocar di Hasson 11mm cannula StandardClass IIa
    805511288K01010102LY
  • X-ONE Trocar Toracico 5mm cannula CortaClass IIa
    805511288K01010104M4