Basic Information
- Number
- HZ 2320977-1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- July 7, 2022
- Expiry Date
- November 18, 2026
- Revision
- 2
- Manufacturer
- SP Medical A/S
Certificate Lifecycle
Device Characteristics
Scopes
10 scopes covering 3 risk classes
Quality Procedure Scope
A0599 - MECHANICAL INFUSION SYSTEMS, SINGLE-USE - OTHER
Quality Procedure Scope
C040101 - CORONARY ARTERY GUIDEWIRES CORONARY ARTERY DIAGNOSTIC GUIDEWIRES
Quality Procedure Scope
C040102 - CORONARY ARTERY GUIDEWIRES CORONARY ARTERY THERAPEUTIC GUIDEWIRES
Quality Procedure Scope
C040201 - PERIPHERAL VASCULAR GUIDEWIRES PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES
Quality Procedure Scope
C040202 - PERIPHERAL VASCULAR GUIDEWIRES PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES
Quality Procedure Scope
C040201 - PERIPHERAL VASCULAR DIAGNOSTIC GUIDEWIRES
Quality Procedure Scope
C040202 - PERIPHERAL VASCULAR THERAPEUTIC GUIDEWIRES
Quality Procedure Scope
U0601 - UROLOGICAL GUIDEWIRES, HYDROPHILIC
Quality Procedure Scope
U0602 - UROLOGICAL GUIDEWIRES, NOT HYDROPHILIC
Quality Procedure Scope
K030202 - ARTHROSCOPY GUIDE WIRES, SINGLE-USE
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.