MDR MDR QMS Issued

KR24/00000078

Manufacturer: LowTem Co., Ltd.
Basic UDI-DIs
0
Scopes
4
Preceding Certs
0
Risk Classes
2
Characteristics
0
Revision
1
1199
Valid for 1199 days
Expiry: September 19, 2029

Basic Information

Number
KR24/00000078
Type
MDR QMS
Legislation
MDR
Issue Date
September 19, 2024
Expiry Date
September 19, 2029
Revision
1
Manufacturer
LowTem Co., Ltd.

Certificate Lifecycle

September 19, 2024 September 19, 2029

Scopes

4 scopes covering 2 risk classes

Quality Procedure Scope

Device Class IIa

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Group Class IIa

MDA0317, MDS1004, MDS1009

Quality Procedure Scope

Device Group Class IIb

MDA0317 EMDN: S900101

Basic UDI-DIs

This Certificate doesn't seem to be associated with any Basic UDI-DIs. If you think that sounds weird, so do we. But that's what the EUDAMED data seems to state.