Basic Information
- Number
- HZ 2016352-1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- July 22, 2024
- Expiry Date
- July 21, 2029
- Manufacturer
- Jiangsu Caina Medical Co.,Ltd.
Certificate Lifecycle
Device Characteristics
Scopes
3 scopes covering 2 risk classes
Quality Procedure Scope
A020102 - INFUSION AND IRRIGATION SYRINGES, SINGLE-USE A020108 - ENTERAL FEEDING SYRINGES A020101 - LOSS-OF-RESISTANCE SYRINGES A070502 - CAPS OR OBTURATORS, PERFORABLE T020603 - MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS) T020604 - MEDICAL USE FACE MASKS, TYPE II AND IIR A1101 - SAMPLE COLLECTION NEUTRAL SWABS A99 - DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER A019001 - BLUNT NEEDLES A010180 - NEEDLES FOR INFUSION AND COLLECTION - ACCESSORIES A0704 - SYSTEMS FOR RECONSTITUTION AND ADMINISTRATION OF PHARMACEUTICALS A070199 - ADAPTERS AND CONNECTORS - OTHER A070501 - CAPS OR OBTURATORS, NON-PERFORABLE
Quality Procedure Scope
A020102 - INFUSION AND IRRIGATION SYRINGES, SINGLE-USE
Quality Procedure Scope
A010101 - HYPODERMIC NEEDLES A020102 - INFUSION AND IRRIGATION SYRINGES, SINGLE-USE A010102 - BUTTERFLY NEEDLES A020106 - INSULIN SYRINGES, SINGLE-USE A010105 - NEEDLES FOR COLLECTION UNDER VACUUM A020108 - ENTERAL FEEDING SYRINGES A010601 - CARPULE NEEDLES A01010502 - NEEDLES FOR COLLECTION UNDER VACCUM, W/O SAFETY SYSTEMS A01010501 - NEEDLES FOR COLLECTION UNDER VACUUM, WITH SAFETY SYSTEMS C010101 - PERIPHERAL I.V. CATHETERS A030201 - EXTENSIONS A02010701 - PREFILLED SYRINGES WITH STERILE PHYSIOLOGICAL SOLUTION
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.