IVDR IVDR QMS Issued

HX 1939197-1

Manufacturer: Attomol GmbH
Basic UDI-DIs
0
Scopes
1
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
Rev. 0
1059
Valid for 1059 days
Expiry: May 2, 2029

Basic Information

Number
HX 1939197-1
Type
IVDR QMS
Legislation
IVDR
Issue Date
May 3, 2024
Expiry Date
May 2, 2029
Revision
Rev. 0
Manufacturer
Attomol GmbH

Certificate Lifecycle

May 3, 2024 May 2, 2029

Scopes

Quality Procedure Scope

Device Group Class C

GENETIC TESTING IVR 0402: Devices intended to be used to predict genetic disease/disorder risk and prognosis W01060101 - MONOGENETIC DISORDERS W01060102 - POLYGENETIC DISORDERS W01060104 - POLYMORPHISMS W010699 - GENETIC TESTS - OTHER

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.