KiiltoClean Oy

Certificate CR-03-1201-785-22

Rev. 01Issued

Valid until: May 11, 2027

Certificate CR-03-1201-785-22 is a valid Quality management system issued to KiiltoClean Oy and registered in EUDAMED. Valid until May 11, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: CR-03-1201-785-22
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0537CR-03-1201-785-2201

Validity

Issued: May 11, 2022
Valid from: May 12, 2022
Valid until: May 11, 2027

Notified body

Notified body: Eurofins Electric & Electronics Finland Oy
Notified body SRN: 0537
Notified body country: Finland

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: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa13

13 scopes

MDN 1211 Non-active non-implantable devices for disinfecting, cleaning and rinsing
Class IIa
Kiilto Pro Erisan Oxy+
Class IIa
Kiilto Pro Easydes
Class IIa
Kiilto Pro MD Des Etanol 75
Class IIa
Antibac Overflatedesinfeksjon 75%
Class IIa
Antibac Dental 75% overflatedes
Class IIa
Kiilto Pro MD Des Etanol 75+
Class IIa
Antibac Overflatedesinfeksjon 75% m. tensid
Class IIa
Antibac Dental Overflate+ 75% m/tensid
Class IIa
Antibac Overflatedesinfeksjon Premium 88,8%
Class IIa
Kiilto Pro MD Des IPA 45+
Class IIa
Kiilto Pro MD Instru Des 45+
Class IIa
Kiilto Pro Erisan Des
Class IIa

Documents

LanguagesEN