HZ 2156843-1
Basic Information
- Number
- HZ 2156843-1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- December 18, 2024
- Expiry Date
- November 21, 2028
- Revision
- 1
Certificate Lifecycle
Device Characteristics
Scopes
3 scopes covering 3 risk classes
Quality Procedure Scope
K020101 - MONO- AND BIPOLAR DEVICES, SINGLE-USE MONO- AND BIPOLAR SURGICAL INSTRUMENTS, SINGLE-USE - Disposable Endoscopic Submucosal Dissection Knives
Quality Procedure Scope
G030101 - GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - Gastrointestinal and Biliary Balloon Catheters - 3-Stage Balloon Dilation Catheters G030201 - DIGESTIVE ENDOSCOPY, NEEDLES - Injection Needles G030301 - POLYPECTOMY SNARES - Disposable Cold Snares G030501 - DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES - Disposable Grasping Forceps - Stone Extraction Baskets - Stone Extraction Balloons G030801 - GASTROINTESTINAL ENDOSCOPY, FORCEPS, SINGLE-USE - Disposable Non-electric Biopsy Forceps R070201 - BRONCHOSCOPIC SURGERY FORCEPS, SINGLE-USE - Disposable Non-electric Biopsy Forceps G030899 - INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER - Non-vascular Guidewires G010102 - CARDIAS DILATATION TUBES - Bougie Dilators
Quality Procedure Scope
R070207 - BRONCHOSCOPIC SURGERY CANNULAS, SINGLE-USE - Disposable Spray Catheters G030899 - INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER - Disposable Spray Catheters - Polyp Traps Z120290 - VARIOUS INSTRUMENTS FOR ENDOSCOPY AND MINI-INVASIVE SURGERY - Biopsy Valves G030101 - GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - Balloon Inflators R070203 - BRONCOPULMONARY ENDOSCOPY BRUSHES, SINGLE-USE - Disposable Cytology Brushes G030803 - GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BRUSHES - Disposable Cytology Brushes
Preceding Certificates
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.