MDR MDR QMS Issued

0425-MDR-030020-00

Manufacturer: ENABLE INNOVATIONS SRL
Basic UDI-DIs
0
Scopes
5
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
00

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579
Valid for 579 days
Expiry: February 26, 2028

Basic Information

Number
0425-MDR-030020-00
Type
MDR QMS
Legislation
MDR
Issue Date
February 27, 2023
Expiry Date
February 26, 2028
Revision
00
Manufacturer
ENABLE INNOVATIONS SRL

Certificate Lifecycle

February 27, 2023 February 26, 2028

Scopes

5 scopes covering 1 risk classes

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Class IIb

Quality Procedure Scope

Device Group Class IIb

Gocce oculari monodose e polidose Single-dose and multidose eye drops

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.