MDR MDR QA Issued

DZ 2049691-1

Basic UDI-DIs
0
Scopes
2
Preceding Certs
0
Risk Classes
2
Characteristics
1
Revision
0
569
Valid for 569 days
Expiry: December 29, 2027

Basic Information

Number
DZ 2049691-1
Type
MDR QA
Legislation
MDR
Issue Date
December 30, 2022
Expiry Date
December 29, 2027

Certificate Lifecycle

December 30, 2022 December 29, 2027

Device Characteristics

Sterile

Scopes

2 scopes covering 2 risk classes

Quality Procedure Scope

Device Group Class IIa

A010101 - HYPODERMIC NEEDLES - Disposable Hypodermic Needles - Disposable Safety Hypodermic Needles - Disposable Insulin Pen Needles A010102 - BUTTERFLY NEEDLES - Disposable Scalp Vein Sets - Disposable Safety Scalp Vein Sets A020102 - INFUSION AND IRRIGATION DISPOSABLE SYRINGES - Disposable Syringes - Disposable Safety Syringes A020106 - SINGLE-USE INSULIN SYRINGES - Disposable Insulin Syringes A030101 - INFUSION CONTROLLERS - Disposable Burette Infusion Sets - Disposable Infusion Sets - Disposable Transfusion Sets - Disposable Transfusion Sets without Needle

Quality Procedure Scope

Device Group Class I Sterile

A030201 - EXTENSIONS - Disposable Extension Sets A0703 - STOPCOCKS - 3-way Stop Cocks A020108 - SYRINGES FOR ENTERAL FEEDING - Disposable Enteral Feeding Syringes T020603 - MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS) - Disposable Medical Face Masks A020604 - MEDICAL USE FACE MASKS, TYPE II AND IIR - Disposable Medical Face Masks A020102 - INFUSION AND IRRIGATION DISPOSABLE SYRINGES - Disposable Syringes without Needle - Disposable Syringes with Catheter Tips A030101 - INFUSION CONTROLLERS - Disposable Burette Infusion Sets without needle - Disposable Infusion Sets without needle

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.