Basic Information
- Number
- HZ 2044483-1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- May 11, 2024
- Expiry Date
- September 12, 2028
- Revision
- 1
- Manufacturer
- Brun Medical Co., Ltd.
Certificate Lifecycle
Device Characteristics
Scopes
2 scopes covering 2 risk classes
Quality Procedure Scope
A019013 - PERCUTANEOUS NEEDLES - Introducer Needles A020104 - SYRINGES FOR INJECTORS, SINGLE-USE - Angiographic Syringe and Accessories A060102 - SURGICAL DRAINAGE CONNECTION MEDICAL TUBES - Pressure connecting tubes - Connecting tubes A0703 - STOPCOCKS - Manifold C040202 - PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES - Guide Wire C0502 - CARDIOVASCULAR INTRODUCER SHEATHS, VALVED - Introducer sheaths U0602 - UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC - Non-vascular guide wires U100102 - POSTPARTUM INTRAUTERINE CATHETERS - Balloon Uterine Stents - Postpartum Balloons U100199 - OBSTETRICAL CATHETERS – OTHER - Cervical Ripening Balloons
Quality Procedure Scope
A020104 - SYRINGES FOR INJECTORS, SINGLE-USE - Dose-control Syringe C0699 - CARDIOVASCULAR SURGERY INSTRUMENTS, SINGLE-USE - OTHER - Balloon Inflation Devices - Balloon Inflation Device Sets C900102 - HAEMOSTASIS ADAPTORS - Y Connector Sets C900103 - PERCUTANEOUS ARTERIAL ACCESS HAEMOSTASIS SYSTEMS - Radial Artery Tourniquets
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.