Basic Information
- Number
- HZ 2110300-1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- August 1, 2024
- Expiry Date
- July 31, 2029
- Manufacturer
- Yangzhou Medline Industry Co., Ltd.
Certificate Lifecycle
Device Characteristics
Scopes
2 scopes covering 2 risk classes
Quality Procedure Scope
A020102-INFUSION AND IRRIGATION SYRINGES, SINGLE-USE - Disposable Syringes - Auto-disable Syringes - Safety Auto-disable Syringes - Disposable Safety Syringes - Retractable Safety Syringes A070103-INFUSION LINES ADAPTERS AND CONNECTORS - Three-way Stopcocks A019001-BLUNT NEEDLES - Dispensing Needles A020108-ENTERAL FEEDING SYRINGES - Disposable Feeding Syringes A060301-COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE - Disposable Urine Bags A030101-INFUSION CONTROLLERS - Infusion Sets A1101-SAMPLE COLLECTION NEUTRAL SWABS - Specimen Collection Swabs V9099-VARIOUS DEVICES NOT INCLUDED IN OTHER CLASSES - OTHER - Surgical Brushes T020604-MEDICAL USE FACE MASKS, TYPE II AND IIR - Disposable Medical Masks
Quality Procedure Scope
A020106-INSULIN SYRINGES, SINGLE-USE - Disposable Insulin Syringes - Disposable Safety Insulin Syringes A020102-INFUSION AND IRRIGATION SYRINGES, SINGLE-USE - Disposable Syringes - Auto-disable Syringes - Safety Auto-disable Syringes - Disposable Safety Syringes - Disposable Syringe with safety needles - Retractable Safety Syringes A010102-BUTTERFLY NEEDLES - Scalp Vein Sets - Safety Scalp Vein Sets A010105-NEEDLES FOR COLLECTION UNDER VACUUM - Vacuum Blood Collection Needles - Safety Vacuum Blood Collection Needles A010101-HYPODERMIC NEEDLES - Hypodermic Needles - Safety Needles A030101-INFUSION CONTROLLERS - Infusion Sets C010101-PERIPHERAL I.V. CATHETERS - IV Catheters
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.