Basic Information
- Number
- DZ 2067318-1
- Type
- MDR QA
- Legislation
- MDR
- Issue Date
- June 7, 2022
- Expiry Date
- March 29, 2027
- Manufacturer
- Hubei V-Medical Products Co.,Ltd.
Certificate Lifecycle
Device Characteristics
Scopes
2 scopes covering 2 risk classes
Quality Procedure Scope
M020102 - COTTON GAUZES, FOLDED M020104 - STARCHED COTTON GAUZES M020199 - COTTON GAUZES – OTHER M020201 - NON-WOVEN FOLDED GAUZES M020202 - NON-WOVEN LAPAROTOMY GAUZES M0299 - GAUZES - OTHER M030101 - HYDROPHILIC GAUZE BANDAGES M030301 - ELASTIC FIXING BANDAGES M040301 - EYE PADS, COTTON OR NON-WOVEN MATERIALS T020101 - INCISION DRAPES T0202 - SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) T020401 - STANDARD SURGICAL GOWNS T0205 - NON-SURGICAL GOWNS (EXCLUDING PERSONAL PROTECTIVE EQUIPMENT - PPE) T020603 - MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS) T020604 - MEDICAL USE FACE MASKS, TYPE II AND IIR T030101 - COVER CAPS, INSTRUMENTS AND EQUIPMENT V0102 - STAPLE REMOVER KNIVES, SINGLE-USE V0199 - CUTTING DEVICES, SINGLE-USE - OTHER V9012 - NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE W050102 - URINE COLLECTION DEVICES W050190 - SAMPLES COLLECTION DEVICES - VARIOUS
Quality Procedure Scope
M020102 - COTTON GAUZES, FOLDED M020103 - LAPAROTOMY COTTON GAUZES
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.