MDR MDR QMS Supplemented Expired

HZ 2091024-1

Basic UDI-DIs
0
Scopes
3
Preceding Certs
1
Risk Classes
3
Characteristics
1
Revision
7
206
Expired 206 days ago
Expiry: November 13, 2025

Basic Information

Number
HZ 2091024-1
Type
MDR QMS
Legislation
MDR
Issue Date
October 23, 2024
Expiry Date
November 13, 2025 Expired
Revision
7

Certificate Lifecycle

October 23, 2024 November 13, 2025

Device Characteristics

Sterile

Scopes

3 scopes covering 3 risk classes

Quality Procedure Scope

Device Group Class IIa

A010101 – HYPODERMIC NEEDLES - Insulin Pen Needles - Safety Insulin Pen Needles - Safety Sterile Needles - Sterile Needles A010103 – NEEDLES AND KITS FOR IMPLANTABLE SYSTEMS (PORT) - Safety Huber Needles - Regular Huber Needles A010105 – NEEDLES FOR COLLECTION UNDER VACUUM - Safety Winged Blood Collection Sets - Winged Blood Collection Sets A010201 – NEEDLES AND KITS - HISTOLOGICAL AND CYTOLOGICAL BIOPSY OF SOFT TISSUES - Co-axial Biopsy Devices - Fine Biopsy Needles - Semi-automatic Biopsy Needles - Automatic Biopsy Needles A010202 – BONE MARROW BIOPSY NEEDLES AND KITS - Bone Marrow Biopsy Needles A020102 – INFUSION AND IRRIGATION SYRINGES, SINGLE-USE - Safety Sterile Syringes - Sterile Syringes with Safety Needle Combo - Sterile Syringes with Fixed Needles - Auto-Disable Syringes A020106 – INSULIN SYRINGES, SINGLE-USE - Insulin Syringes - Safety Insulin Syringes A019012 – BREAST NODULES AND OTHER STRUCTURES LOCALISATION NEEDLES AND SYSTEMS - Breast Localization Wires A060201 - EXTERNAL DRAINAGE CATHETERS AND KITS (ABSCESSES, GALLSTONES, CYSTS) - Multipurpose Drainage Catheters V010401 – LANCETS WITH SAFETY SYSTEMS, SINGLE-USE - Heel Blood Lancets - Safety Blood Lancets V010402 – LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE - Blood Lancets G030201 - DIGESTIVE ENDOSCOPY, NEEDLES - Endoscopic Injection Needles G030801 - GASTROINTESTINAL ENDOSCOPY, FORCEPS, SINGLE-USE - Single Use Biopsy Forceps G030301 - POLYPECTOMY SNARES - Cold Polypectomy Snares U090101 –URINARY STONE RETRIEVAL BASKETS G030501 –DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES - Stone Retrieval Baskets

Quality Procedure Scope

Device Group Class I Sterile

A020102 – INFUSION AND IRRIGATION SYRINGES, SINGLE-USE - Sterile Syringes without Needles A070103 – INFUSION LINES ADAPTERS AND CONNECTORS - Needleless Adapters - Heparin Plugs A019001 – BLUNT NEEDLES - Blunt Needles A010180 – NEEDLES FOR INFUSION AND COLLECTION - ACCESSORIES - Blood Collection Tube Holders G030704 – COLON DYE SPRAYING CATHETERS - Spraying Catheters for Single Use G030801 – GASTROINTESTINAL ENDOSCOPY, FORCEPS, SINGLE USE - Single Use Grasping Forceps G030803 – GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BRUSHES - Single Use Cytology Brushes G030501 – DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES - Retrieval Nets A030201 –EXTENSIONS - Extension Sets

Quality Procedure Scope

Device Group Class IIb

G030202 – DIGESTIVE ENDOSCOPY, HAEMOSTASIS DEVICES – DIGESTIVE ENDOSCOPY, HAEMOSTASIS CLIPS - Single Use Hemoclips

Preceding Certificates

HZ 2091024-1 Supplemented
Issued: June 20, 2024 Expires: November 13, 2025

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.