MDR MDR QMS Issued

JP24/00000273

Manufacturer: MIKASA X-RAY Co.,Ltd.
Basic UDI-DIs
0
Scopes
2
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
1

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1163
Valid for 1163 days
Expiry: October 1, 2029

Basic Information

Number
JP24/00000273
Type
MDR QMS
Legislation
MDR
Issue Date
October 1, 2024
Expiry Date
October 1, 2029
Revision
1
Manufacturer
MIKASA X-RAY Co.,Ltd.

Certificate Lifecycle

October 1, 2024 October 1, 2029

Scopes

2 scopes covering 1 risk classes

Quality Procedure Scope

Device Group Class IIb

MDA0201, MDS1009, EMDN: Z11039011

Quality Procedure Scope

Device Class IIb

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.