Basic Information
- Number
- DZ 2111577-1
- Type
- MDR QA
- Legislation
- MDR
- Issue Date
- July 23, 2024
- Expiry Date
- July 22, 2029
- Manufacturer
- SHAOXING YIBON MEDICAL CO., LTD.
Certificate Lifecycle
Device Characteristics
Scopes
2 scopes covering 1 risk classes
Quality Procedure Scope
M020106 - COTTON GAUZES IN PIECES - Sterile Gauze Swabs M020102 - COTTON GAUZES, FOLDED - Sterile Gauze Balls M020204 - NON-WOVEN GAUZES IN PIECES - Sterile Non-woven Swabs M020201 - NON-WOVEN FOLDED GAUZES - Sterile Non-woven Balls M040201 - ABSORBENT DRESSINGS WITH CELLULOSE PAD AND NON-WOVEN WRAPS - Sterile Non-woven Absorbent Pads M020203 - NON-WOVEN GAUZE PADS - Non-woven Absorbent Pads M020105 - COTTON GAUZE PADS - Gauze Absorbent Pads M040204 - NON-ADHERENT ABSORBENT DRESSINGS - Non-Adherent Absorbent Pads M040301 - EYE PADS, COTTON OR NON-WOVEN MATERIALS - Sterile gauze eye pads - Sterile Non-woven eye pads - Sterile self adhesive eye pads M040101 - ADHESIVE DRESSINGS, WITH ABSORBENT PAD - Sterile non-woven wound dressing with pads - Sterile film wound dressing with pads - Sterile film wound dressing with pads with frame M040102 - FIXING DRESSINGS - Sterile non-woven wound dressing without pads - Sterile film wound dressing without pads - Sterile film wound dressing without pads with frame - Sterile fixation strips - Sterile fixation dressing Type A - Sterile fixation dressing Type B - Sterile fixation dressing Type C M040406 - POLYURETHANE DRESSINGS - Sterile foam dressing M030301 - ELASTIC FIXING BANDAGES - Conforming bandages M030402 - ELASTIC SUPPORT BANDAGES - Elastic crepe bandages M030101 - HYDROPHILIC GAUZE BANDAGES - Woven gauze bandages T020199 - SURGICAL DRAPES - OTHER - Sterile drape T030102 - COVER SHEATHS, INSTRUMENTS AND EQUIPMENTS - Sterile CVK cover A99 - DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER - Sponge applicator - Cotton applicator - Gauze tipped applicator - Non-woven tipped applicator
Quality Procedure Scope
V9012 - NON-SPECIALIST SURGICAL INSTRUMENTS AND KITS, SINGLE-USE - Medical scissors - Medical scissors with plastic handle - Medical metal forceps - Medical plastic forceps - Kocher forceps - Sterile stylet H900802 - SINGLE-USE NEEDLE HOLDERS - Needle Holder H020101 - MECHANICAL SKIN STAPLERS - Sterile staple removal T0202 - SURGICAL PROCEDURAL KITS (EXCLUDING SURGICAL INSTRUMENT KITS) - Sterile catheterization sets - Sterile suture removal sets - Medical bowl sets - Disinfection sets - Sterile wound dressing sets - Sterile Dialysis Sets - Sterile staple removal sets A060101 - VACUUM AND GRAVITY DRAINAGE SYSTEMS - Drainage sets
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.