Basic Information
- Number
- HZ 2349798-1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- July 23, 2024
- Expiry Date
- July 22, 2029
- Manufacturer
- Zhejiang Chuangxiang Medical Technology Co., LTD.
Certificate Lifecycle
Device Characteristics
Scopes
2 scopes covering 2 risk classes
Quality Procedure Scope
G030501 - DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES - Single Use Grasping Forceps - Single Use Stone Retrieval Baskets R0799 - BRONCOPULMONARY ENDOSCOPY DEVICES, SINGLE-USE - OTHER - Single Use Grasping Forceps - Single Use Cytology Brushes G030499 - ERCP AND SPHINCTEROTOMY DEVICES - OTHER - Single Use Guidewire for endoscopic biliary procedures G030101 - GASTROINTESTINAL ENDOSCOPY, BALLOON CATHETERS - Single Use Balloon Dilatation Catheters R050201 - BRONCHIAL DILATION CATHETERS - Single Use Balloon Dilatation Catheters G030899 - INSTRUMENTS FOR GASTRO-INTESTINAL ENDOSCOPY AND ECO-ENDOSCOPY, SINGLE-USE - OTHER - Disposable Biopsy Valves G030803 - GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BRUSHES - Single Use Cytology Brushes
Quality Procedure Scope
G030801 - GASTROINTESTINAL ENDOSCOPY, FORCEPS, SINGLE-USE - Single Use Biopsy Forceps R070201 - BRONCHOSCOPIC SURGERY FORCEPS, SINGLE-USE - Single Use Biopsy Forceps G030403 - NASO-BILIARY-PANCREATIC TUBES - Single Use Biliary Drainage Catheters G030201 - DIGESTIVE ENDOSCOPY, NEEDLES - Sclerotherapy Needles
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.