Basic Information
- Number
- HZ 2091024-1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- October 23, 2024
- Expiry Date
- November 13, 2025 Expired
- Revision
- 7
- Manufacturer
- Promisemed Hangzhou Meditech Co., Ltd.
Certificate Lifecycle
Device Characteristics
Scopes
3 scopes covering 3 risk classes
Quality Procedure Scope
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
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
G030202 – DIGESTIVE ENDOSCOPY, HAEMOSTASIS DEVICES – DIGESTIVE ENDOSCOPY, HAEMOSTASIS CLIPS - Single Use Hemoclips
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.