MDR MDR QMS Issued

HZ 2081048-1

Basic UDI-DIs
0
Scopes
1
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
0
1201
Valid for 1201 days
Expiry: September 22, 2029

Basic Information

Number
HZ 2081048-1
Type
MDR QMS
Legislation
MDR
Issue Date
September 23, 2024
Expiry Date
September 22, 2029

Certificate Lifecycle

September 23, 2024 September 22, 2029

Scopes

Quality Procedure Scope

Device Group Class IIb

Z110303 - DIAGNOSTIC AND INTERVENTIONAL RADIOLOGY INSTRUMENTS INSTRUMENTS FOR ORTHOPANTOMOGRAPHY AND PANORAMIC DENTAL RADIOLOGY Intended purpose: The product is intended for oral and maxillofacial X-ray cone beam computed tomography, panoramic radiography and cephalometric radiography.

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.