MDR MDR QA Issued

DZ 2512196-1

Basic UDI-DIs
0
Scopes
1
Preceding Certs
0
Risk Classes
1
Characteristics
1
Revision
Rev.0
1076
Valid for 1076 days
Expiry: May 20, 2029

Basic Information

Number
DZ 2512196-1
Type
MDR QA
Legislation
MDR
Issue Date
May 21, 2024
Expiry Date
May 20, 2029
Revision
Rev.0

Certificate Lifecycle

May 21, 2024 May 20, 2029

Device Characteristics

Sterile

Conditions

English

For the following product(s) the conformity assessment is limited to the aspects relating to establishing, securing and maintaining sterile conditions for systems or procedure packs pursuant to Article 22(3), REGULATION (EU) 2017/745: Sterile Surgical Packs

Scopes

Quality Procedure Scope

Device Group Class I Sterile

T020401 - STANDARD SURGICAL GOWNS T020199 - SURGICAL DRAPES - OTHER The scope of certification is limited to the aspects relating to establishing, securing and maintaining sterile conditions. For the following product(s) the conformity assessment is limited to the aspects relating to establishing, securing and maintaining sterile conditions for systems or procedure packs pursuant to Article 22(3), REGULATION (EU) 2017/745: Sterile Surgical Packs

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.