MDR MDR QMS Supplemented

ITH 1281809 1

Manufacturer: OSCAR BOSCAROL SRL
Basic UDI-DIs
0
Scopes
2
Preceding Certs
1
Risk Classes
2
Characteristics
0
Revision
01
530
Valid for 530 days
Expiry: November 21, 2027

Basic Information

Number
ITH 1281809 1
Type
MDR QMS
Legislation
MDR
Issue Date
February 7, 2023
Expiry Date
November 21, 2027
Revision
01
Manufacturer
OSCAR BOSCAROL SRL

Certificate Lifecycle

February 7, 2023 November 21, 2027

Scopes

2 scopes covering 2 risk classes

Quality Procedure Scope

Device Group Class IIb

Oxygen distribution kit for ambulances and emergency vehicles

Quality Procedure Scope

Device Group Class IIa

Active non-implantable devices for extra-corporal circulation, administration or removal of substances and haemapheresis

Preceding Certificates

ITH 1281809 1 Issued
Issued: February 7, 2023 Expires: November 21, 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.