AFERETICA S.R.L.

Certificate ITH 1343916 1

Rev. 2.0Supplemented

Valid until: Oct 17, 2029

Certificate ITH 1343916 1 is a valid Quality management system issued to AFERETICA S.R.L. and registered in EUDAMED. Valid until October 17, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: ITH 1343916 1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1936ITH 1343916 12.0

Validity

Issued: Jul 14, 2025
Valid from: Jul 14, 2025
Valid until: Oct 17, 2029

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: 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: Others

History

Status changes

Supplemented

Supersedes

ITH 1343916 1Quality management systemIssuedOct 18, 2024 → Oct 17, 2029

Scope coverage

Class IIa4Class I1

5 scopes

Dispositivi non impiantabili attivi per il trattamento e la conservazione di cellule, tessuti o organi umani comprese fecondazione in vitro e tecnologie di riproduzione assistita / Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitrofertilisation (IVF) and assisted reproductive technologies (ART)
Class IIa
Altri dispositivi non impiantabili attivi / Other active non-implantable devices
Class I
Dispositivi non impiantabili non attivi per il trattamento e la conservazione di cellule, tessuti o organi umani comprese fecondazione in vitro e tecnologie di riproduzione assistita / Non-active non-implantable devices for processing and preservation of human cells, tissue or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
Class IIa
Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis / Dispositivi non impiantabili attivi per circolazione extracorporea, somministrazione o sottrazione di sostanze ed emaferesi
Class IIa
Dispositivi non impiantabili non attivi per la somministrazione la canalizzazione e la sottrazione di sostanze, compresi i dispositivi per dialisi / Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
Class IIa

Scope coverage

Class IIa4Class I1

5 scopes

Dispositivi non impiantabili attivi per il trattamento e la conservazione di cellule, tessuti o organi umani comprese fecondazione in vitro e tecnologie di riproduzione assistita / Active non-implantable devices for processing and preservation of human cells, tissues or organs including in vitrofertilisation (IVF) and assisted reproductive technologies (ART)
Class IIa
Altri dispositivi non impiantabili attivi / Other active non-implantable devices
Class I
Dispositivi non impiantabili non attivi per il trattamento e la conservazione di cellule, tessuti o organi umani comprese fecondazione in vitro e tecnologie di riproduzione assistita / Non-active non-implantable devices for processing and preservation of human cells, tissue or organs including in vitro fertilisation (IVF) and assisted reproductive technologies (ART)
Class IIa
Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis / Dispositivi non impiantabili attivi per circolazione extracorporea, somministrazione o sottrazione di sostanze ed emaferesi
Class IIa
Dispositivi non impiantabili non attivi per la somministrazione la canalizzazione e la sottrazione di sostanze, compresi i dispositivi per dialisi / Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
Class IIa

Certificate ITH 1343916 1

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Certificate ITH 1343916 1

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer

Documents