MDR MDR QMS Issued

HZ 2365565-1

Basic UDI-DIs
0
Scopes
2
Preceding Certs
0
Risk Classes
2
Characteristics
0
Revision
0
810
Valid for 810 days
Expiry: August 27, 2028

Basic Information

Number
HZ 2365565-1
Type
MDR QMS
Legislation
MDR
Issue Date
August 28, 2023
Expiry Date
August 27, 2028

Certificate Lifecycle

August 28, 2023 August 27, 2028

Device Characteristics

Sterile

Scopes

2 scopes covering 2 risk classes

Quality Procedure Scope

Device Group Class IIa

C01010101 - PERIPHERAL I.V. CATHETERS, W/O SAFETY SYSTEMS C01010102 - PERIPHERAL I.V. CATHETERS, WITH SAFETY SYSTEMS A01010102 - HYPODERMIC PEN NEEDLES

Quality Procedure Scope

Device Group Class IIb

A020203 - REUSABLE SYRINGES CARTRIDGE SYRINGES

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.