TENTECH Inc.

Certificate 2025-MDR/QS-054/A

Rev. 01Supplemented

Valid until: Nov 11, 2030

Certificate 2025-MDR/QS-054/A is a valid Quality management system issued to TENTECH Inc. and registered in EUDAMED. Valid until November 11, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 2025-MDR/QS-054/A
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 22652025-MDR/QS-054/A01

Validity

Issued: Mar 10, 2026
Valid from: Mar 10, 2026
Valid until: Nov 11, 2030

Manufacturer

Manufacturer: TENTECH Inc.
Manufacturer SRN: KR-MF-000035109
Manufacturer country: South Korea

Notified body

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

Covered devices

Electrosurgical UnitClass IIb
880970938TMSY03ZR

Characteristics

Sterile: No
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: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

2025-MDR/QS-054Quality management systemIssuedNov 11, 2025 → Nov 11, 2030

Scope coverage

Class IIb2

2 scopes

Devices for surgery with radiofrequency generator, single-use - accessories
Class IIb
DEVICE
Class IIb

Documents

LanguagesEN