MDR MDR QMS Issued

TNP/MDR/0013/5613/2023

Manufacturer: LiNA Medical ApS
Basic UDI-DIs
0
Scopes
3
Preceding Certs
0
Risk Classes
1
Characteristics
1
Revision
Ver. 01
737
Valid for 737 days
Expiry: June 14, 2028

Basic Information

Number
TNP/MDR/0013/5613/2023
Type
MDR QMS
Legislation
MDR
Issue Date
June 15, 2023
Expiry Date
June 14, 2028
Revision
Ver. 01
Manufacturer
LiNA Medical ApS

Certificate Lifecycle

June 15, 2023 June 14, 2028

Device Characteristics

Sterile

Scopes

3 scopes covering 1 risk classes

Quality Procedure Scope

Device Group Class I Sterile

Akcesoria do histeroskopu / Accessories for hysteroscope

Quality Procedure Scope

Device Class I Sterile

Quality Procedure Scope

Device Class I Sterile

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.