MDR MDR QMS Issued

FI24/1008005

Basic UDI-DIs
0
Scopes
12
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
Issue 1
989
Valid for 989 days
Expiry: February 21, 2029

Basic Information

Number
FI24/1008005
Type
MDR QMS
Legislation
MDR
Issue Date
February 22, 2024
Expiry Date
February 21, 2029
Revision
Issue 1

Certificate Lifecycle

February 22, 2024 February 21, 2029

Scopes

12 scopes covering 1 risk classes

Quality Procedure Scope

Device Class IIa

Quality Procedure Scope

Device Group Class IIa

EMDN Z12062899 TENS Therapy Device

Quality Procedure Scope

Device Group Class IIa

EMDN Z1203020501 Electronic Blood Pressure Monitor

Quality Procedure Scope

Device Group Class IIa

EMDN V0301010202 Infrared Thermometer

Quality Procedure Scope

Device Group Class IIa

EMDN Z12080103 Fetal Doppler

Quality Procedure Scope

Device Group Class IIa

EMDN Z12080101 Fetal Monitor

Quality Procedure Scope

Device Group Class IIa

EMDN Z1203020408 Pulse Oximeter

Quality Procedure Scope

Device Class IIa

Quality Procedure Scope

Device Class IIa

Quality Procedure Scope

Device Class IIa

Quality Procedure Scope

Device Class IIa

Quality Procedure Scope

Device Class IIa

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.