IVDR IVDR QMS Issued

HX 1485480-1

Manufacturer: Terumo Corporation
Basic UDI-DIs
0
Scopes
1
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
0
266
Valid for 266 days
Expiry: March 2, 2027

Basic Information

Number
HX 1485480-1
Type
IVDR QMS
Legislation
IVDR
Issue Date
June 2, 2022
Expiry Date
March 2, 2027
Manufacturer
Terumo Corporation

Certificate Lifecycle

June 2, 2022 March 2, 2027

Device Characteristics

Sterile

Scopes

Quality Procedure Scope

Device Group Class A

Products of class A, sterile: DEVICES FOR SAMPLES TRANSPORT (non-generic laboratory products) IVR 0803: Specimen receptacles referred to in point 2.5 (rule 5), under c), of Annex VIII to Regulation (EU) 2017/746 W050201 - SAMPLES TRANSPORT, CONTAINERS The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions

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.