MDR MDR QMS Issued Expired

TNP/MDR/0009/4588/2023

Manufacturer: Angionica sp. z o.o.
Basic UDI-DIs
0
Scopes
2
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
Ver. 01
119
Expired 119 days ago
Expiry: February 9, 2026

Basic Information

Number
TNP/MDR/0009/4588/2023
Type
MDR QMS
Legislation
MDR
Issue Date
February 10, 2023
Expiry Date
February 9, 2026 Expired
Revision
Ver. 01
Manufacturer
Angionica sp. z o.o.

Certificate Lifecycle

February 10, 2023 February 9, 2026

Scopes

2 scopes covering 1 risk classes

Quality Procedure Scope

Device Group Class IIa

Aparat do nieinwazyjnej diagnostyki zaburzeń krążenia metodą FSMF / A device for non-invasive diagnosis of vascular circulatory disorders using the FMSF method

Quality Procedure Scope

Device Class IIa

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.