Basic UDI-DIs
0
Scopes
5
Preceding Certs
0
Risk Classes
1
Characteristics
1
Revision
Rev.0
952
Valid for 952 days
Expiry: January 16, 2029
Basic Information
- Number
- HZ 1007442-1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- January 17, 2024
- Expiry Date
- January 16, 2029
- Revision
- Rev.0
- Manufacturer
- Leina-Werke GmbH
Certificate Lifecycle
Today
January 17, 2024
January 16, 2029
Device Characteristics
Sterile
Conditions
English
The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions
Scopes
5 scopes covering 1 risk classes
Quality Procedure Scope
Device Group
Class I
Sterile
M020102 - COTTON GAUZES, FOLDED
Quality Procedure Scope
Device Group
Class I
Sterile
M020203 - NON-WOVEN GAUZE PADS
Quality Procedure Scope
Device Group
Class I
Sterile
M030102 - NON-WOVEN BANDAGES
Quality Procedure Scope
Device Group
Class I
Sterile
M030302 - PROTECTION SYSTEMS
Quality Procedure Scope
Device Group
Class I
Sterile
M040301 - EYE PADS, COTTON OR NON-WOVEN MATERIALS
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.