MDR MDR QMS Issued

HZ 2002480-1

Manufacturer: Togo Medikit Co., Ltd.
Basic UDI-DIs
0
Scopes
2
Preceding Certs
0
Risk Classes
2
Characteristics
0
Revision
Rev.3
291
Valid for 291 days
Expiry: March 27, 2027

Basic Information

Number
HZ 2002480-1
Type
MDR QMS
Legislation
MDR
Issue Date
April 10, 2024
Expiry Date
March 27, 2027
Revision
Rev.3
Manufacturer
Togo Medikit Co., Ltd.

Certificate Lifecycle

April 10, 2024 March 27, 2027

Device Characteristics

Sterile

Scopes

2 scopes covering 2 risk classes

Quality Procedure Scope

Device Group Class IIa

A010401 - ARTERIOVENOUS FISTULA NEEDLES C010101 - PERIPHERAL I.V. CATHETERS C0504 - ARTERIAL INTRODUCTION SETS

Quality Procedure Scope

Device Group Class III

C010401 - ANGIOGRAPHY AND HEMODYNAMIC DEVICES CARDIAC ANGIOGRAPHY DEVICES

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.