LowTem Co., Ltd.

Certificate KR24/00000078

Rev. 3Supplemented

Valid until: Sep 19, 2029

Certificate KR24/00000078 is a valid Quality management system issued to LowTem Co., Ltd. and registered in EUDAMED. Valid until September 19, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: KR24/00000078
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 1639KR24/000000783

Validity

Issued: Nov 18, 2025
Valid from: Nov 18, 2025
Valid until: Sep 19, 2029

Manufacturer

Manufacturer: LowTem Co., Ltd.
Manufacturer SRN: KR-MF-000016177
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: 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

KR24/00000078Quality management systemSupplementedSep 19, 2024 → Sep 19, 2029

Scope coverage

Class IIa2Class IIb2

4 scopes

MDA0317, MDS1004, MDS1009
Class IIa
MDA0317 EMDN: S900101
Class IIb
Low temperature H2O2 Sterilizers
Class IIa
H2O2 Sterilizing Agents
Class IIb

Documents

LanguagesEN