MDR MDR QMS Supplemented

KR23/00000154

Manufacturer: RF Medical Co., Ltd.
Basic UDI-DIs
0
Scopes
6
Preceding Certs
1
Risk Classes
1
Characteristics
0
Revision
3
836
Valid for 836 days
Expiry: September 21, 2028

Basic Information

Number
KR23/00000154
Type
MDR QMS
Legislation
MDR
Issue Date
January 10, 2024
Expiry Date
September 21, 2028
Revision
3
Manufacturer
RF Medical Co., Ltd.

Certificate Lifecycle

January 10, 2024 September 21, 2028

Device Characteristics

Sterile

Scopes

6 scopes covering 1 risk classes

Quality Procedure Scope

Device Group Class IIb

MDA0312, MDS1009, EMDN : Z120109

Quality Procedure Scope

Device Group Class IIb

MDA0312, MDS1005, EMDN: K020101

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Class IIb

Preceding Certificates

KR23/00000154 Amended
Issued: October 17, 2023 Expires: September 21, 2028

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.