GIOCHEMICA S.R.L.

Certificate 0425-MDR-030078-00

Rev. 00Issued

Valid until: May 9, 2029

Certificate 0425-MDR-030078-00 is a valid Quality management system issued to GIOCHEMICA S.R.L. and registered in EUDAMED. Valid until May 9, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 0425-MDR-030078-00
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 04250425-MDR-030078-0000

Validity

Issued: May 10, 2024
Valid from: May 10, 2024
Valid until: May 9, 2029

Notified body

Notified body: ICIM S.P.A.
Notified body SRN: 0425
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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb17Class IIa4

20 scopes

Disinfectant solutions used for disinfection of invasive medical devices
Class IIb
Disinfectant solutions used for disinfection or sterilization of medical devices
Class IIbClass IIa
Glutaraldehyde for the disinfection of medical devices
Class IIb
Orthophtalaldehyde for the disinfection of medical devices
Class IIb
Chlorhexidine for the disinfection of medical devices
Class IIb
Chlorhexidine in asscociation for the disinfection of medical devices – other
Class IIb
Chlorhexidine in asscociation for the disinfection of medical devices – other
Class IIa
Hypochlorite for the disinfection of medical devices
Class IIb
Hypochlorite for the disinfection of medical devices
Class IIa
Associated hypochlorites for the disinfection of medical devices – other
Class IIb
Dichloroisocyanurates for the disinfection of medical devices
Class IIb
Peracetic and acetic acid with hydrogen peroxide for the disinfection of medical devices
Class IIb
Associated peracetic acid for the disinfection of medical devices – other
Class IIb
Peracetic acid and adamantan derivatives for the disinfection of medical devices
Class IIb
Polyphenols
Class IIb
Polyphenols with detergentsfor the disinfection of medical devices
Class IIb
Ethanol for the disinfection of medical devices
Class IIb
Isopropyl alcohol for the disinfection of medical devices
Class IIb
Ammonium salts for the disinfection of medical devices
Class IIb
Ammonium salts for the disinfection of medical devices
Class IIa

Scope coverage

Class IIb17Class IIa4

20 scopes

Disinfectant solutions used for disinfection of invasive medical devices
Class IIb
Disinfectant solutions used for disinfection or sterilization of medical devices
Class IIbClass IIa
Glutaraldehyde for the disinfection of medical devices
Class IIb
Orthophtalaldehyde for the disinfection of medical devices
Class IIb
Chlorhexidine for the disinfection of medical devices
Class IIb
Chlorhexidine in asscociation for the disinfection of medical devices – other
Class IIb
Chlorhexidine in asscociation for the disinfection of medical devices – other
Class IIa
Hypochlorite for the disinfection of medical devices
Class IIb
Hypochlorite for the disinfection of medical devices
Class IIa
Associated hypochlorites for the disinfection of medical devices – other
Class IIb
Dichloroisocyanurates for the disinfection of medical devices
Class IIb
Peracetic and acetic acid with hydrogen peroxide for the disinfection of medical devices
Class IIb
Associated peracetic acid for the disinfection of medical devices – other
Class IIb
Peracetic acid and adamantan derivatives for the disinfection of medical devices
Class IIb
Polyphenols
Class IIb
Polyphenols with detergentsfor the disinfection of medical devices
Class IIb
Ethanol for the disinfection of medical devices
Class IIb
Isopropyl alcohol for the disinfection of medical devices
Class IIb
Ammonium salts for the disinfection of medical devices
Class IIb
Ammonium salts for the disinfection of medical devices
Class IIa

Certificate 0425-MDR-030078-00

Overview

Validity

Notified body

Covered devices

Characteristics

History

Scope coverage

Certificate 0425-MDR-030078-00

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Scope coverage

Documents

Manufacturer

Documents