MDR MDR QMS Issued

HZ 2066688-1

Manufacturer: ASTEC CO.,Ltd
Basic UDI-DIs
0
Scopes
1
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
Rev.0
1282
Valid for 1282 days
Expiry: December 12, 2029

Basic Information

Number
HZ 2066688-1
Type
MDR QMS
Legislation
MDR
Issue Date
December 13, 2024
Expiry Date
December 12, 2029
Revision
Rev.0
Manufacturer
ASTEC CO.,Ltd

Certificate Lifecycle

December 13, 2024 December 12, 2029

Device Characteristics

Sterile

Scopes

Quality Procedure Scope

Device Group Class IIa

Products of class IIa: U080299 - DEVICES FOR ASSISTED REPRODUCTION - OTHER U080206 - CULTURE PLATES FOR ASSISTED REPRODUCTION

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.