FINEMEDIX CO., LTD.

Certificate 2026-MDR/QS-029

Rev. 00Issued

Valid until: Jun 2, 2031

Certificate 2026-MDR/QS-029 is a valid Quality management system issued to FINEMEDIX CO., LTD. and registered in EUDAMED. Valid until June 2, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: 2026-MDR/QS-029
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652026-MDR/QS-02900

Validity

Issued: Jun 2, 2026
Valid from: Jun 2, 2026
Valid until: Jun 2, 2031

Manufacturer

Manufacturer: FINEMEDIX CO., LTD.
Manufacturer SRN: KR-MF-000021680
Manufacturer country: South Korea

Notified body

Notified body
Notified body SRN: 2265
Notified body country: Slovakia

Covered devices

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 IIa6

6 scopes

ASPIRATION FINE NEEDLES AND KITS
Class IIa
ELECTROSURGERY ELECTRODES, SINGLE-USE
Class IIa
ENDOTHERAPY DEVICES - OTHER ACCESSORIES
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa

Documents

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