C-K DENTAL IND.CO.,LTD.

Certificate KR24/0000049

Rev. 1Issued

Valid until: Jun 24, 2029

Certificate KR24/0000049 is a valid Quality management system issued to C-K DENTAL IND.CO.,LTD. and registered in EUDAMED. Valid until June 24, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: KR24/0000049
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1639KR24/00000491

Validity

Issued: Jun 24, 2024
Valid from: Jun 24, 2024
Valid until: Jun 24, 2029

Manufacturer

Manufacturer: C-K DENTAL IND.CO.,LTD.
Manufacturer SRN: KR-MF-000022929
Manufacturer country: South Korea

Notified body

Notified body
Notified body SRN: 1639
Notified body country: Belgium

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: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa3

3 scopes

MDN1202, MDS1005
Class IIa
Sterile single use dental needles
Class IIa
Sterile single use endodontic irrigation needles
Class IIa

Documents

LanguagesEN