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
Today
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.