MDR MDR QMS Supplemented

005-00-01-MDR

Manufacturer: TECNOFAR s.p.a.
Basic UDI-DIs
0
Scopes
2
Preceding Certs
1
Risk Classes
1
Characteristics
0
Revision
01
497
Valid for 497 days
Expiry: October 19, 2027

Basic Information

Number
005-00-01-MDR
Type
MDR QMS
Legislation
MDR
Issue Date
December 6, 2024
Expiry Date
October 19, 2027
Revision
01
Manufacturer
TECNOFAR s.p.a.

Certificate Lifecycle

December 6, 2024 October 19, 2027

Device Characteristics

Sterile

Scopes

2 scopes covering 1 risk classes

Quality Procedure Scope

Device Group Class IIa

Non-active non-implantable devices for administration, channelling and removal of substances

Quality Procedure Scope

Device Class IIa

Preceding Certificates

005-00-00-MDR Issued
Issued: October 20, 2022 Expires: October 19, 2027

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.