MDR MDR QMS Issued

MY24/00000440

Manufacturer: TG MEDICAL SDN. BHD.
Basic UDI-DIs
0
Scopes
3
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
1
1206
Valid for 1206 days
Expiry: September 27, 2029

Basic Information

Number
MY24/00000440
Type
MDR QMS
Legislation
MDR
Issue Date
September 27, 2024
Expiry Date
September 27, 2029
Revision
1
Manufacturer
TG MEDICAL SDN. BHD.

Certificate Lifecycle

September 27, 2024 September 27, 2029

Device Characteristics

Sterile

Scopes

3 scopes covering 1 risk classes

Quality Procedure Scope

Device Class IIa

Quality Procedure Scope

Device Class IIa

Quality Procedure Scope

Device Group Class IIa

MDN1214, MDS1005

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.