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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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Pall International SARL

Certificate ECM24MDR007

Rev. 1Supplemented
Valid until
Sep 8, 2029

Overview

Certificate number
ECM24MDR007
Certificate type
Quality management system
Certificate status
Supplemented
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
2
Certificate ID
1282ECM24MDR0071

Validity

Issued
Jul 17, 2025
Valid from
Jul 17, 2025
Valid until
Sep 8, 2029

Notified body

Notified body
ENTE CERTIFICAZIONE MACCHINE SRL
Notified body SRN
1282
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
Yes
Mechanism of scrutiny
No
Intended medical purpose
No
SPP applicable
No
Conditions applicable
No
MOS outside EUDAMED
No
QMS/MOS type
Class IIb only

History

Status changes

  • Supplemented

Supersedes

  • ECM24MDR007Quality management systemIssuedSep 9, 2024 → Sep 8, 2029

Scope coverage

Class IIa20Class IIb3Class I2

25 scopes

  • Pall Stem Cell Processing System
    Class IIb
  • Pall Stem Cell Transplant System
    Class IIb
  • Pall Freezing Bag -25mL, with Separable Chamber
    Class IIb
  • Pall Ultipor 25 Breathing System Filter
    Class IIa
  • Pall Breathing System Filter
    Class IIa
  • Pall Ultipor 100 Breathing System Filter
    Class IIa
  • Pall Ultipor 50 Breathing System Filter
    Class IIa
  • Pall Ultipor 25 Breathing System Filter
    Class IIa
  • Pall ORO Gas Line Filter
    Class IIa
  • Pall Insufflator Gas Line Filter
    Class IIa
  • Pall Supor AEF Filter
    Class IIa
  • Pall Nanodyne ELD Filter
    Class IIa
  • Pall Lipipor NEO Filter
    Class IIa
  • Pall Lipipor NLF Filter
    Class IIa
  • Pall Lipipor TNA Filter
    Class IIa
  • Pall PharmAssure 25mm Syringe Filter with Low Protein Binding Supor Membrane
    Class IIa
  • Gardian 25mm Syringe Filters, Sterile
    Class IIa
  • Pall PharmAssure 32mm Syringe Filter with Low Protein Binding Supor Membrane
    Class IIa
  • Gardian 25mm Syringe Filters, Sterile
    Class IIa
  • Pall Syringe Filter 13mm, Polyester Screen
    Class IIa
1 / 2

Documents

LanguagesENIT

Manufacturer

Manufacturer
Pall International SARL
Manufacturer SRN
CH-MF-000023177
Manufacturer country
Switzerland