Basic UDI-DIs
0
Scopes
6
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
Rev. 3
146
Expired 146 days ago
Expiry: January 14, 2026
Basic Information
- Number
- HZ 1198082-1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- November 14, 2022
- Expiry Date
- January 14, 2026 Expired
- Revision
- Rev. 3
- Manufacturer
- KULZER GmbH
Certificate Lifecycle
November 14, 2022
January 14, 2026
Scopes
6 scopes covering 1 risk classes
Quality Procedure Scope
Device Group
Class IIa
Q010104 - DENTAL PROCEDURE DEVICES - VARIOUS
Quality Procedure Scope
Device Group
Class IIa
Q019008 - DENTINAL DESENSITISERS
Quality Procedure Scope
Device Group
Class IIa
Q010101 - DENTAL RESTORATION DEVICES
Quality Procedure Scope
Device Group
Class IIa
Q010699 - MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER
Quality Procedure Scope
Device Group
Class IIa
Q010201 - DENTAL IMPRESSION MATERIALS
Quality Procedure Scope
Device Group
Class IIa
Q010601 - DENTAL ALLOYS
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.