MDR MDR QMS Issued

HZ 2058519-1

Basic UDI-DIs
0
Scopes
1
Preceding Certs
0
Risk Classes
1
Characteristics
0
Revision
1
547
Valid for 547 days
Expiry: December 8, 2027

Basic Information

Number
HZ 2058519-1
Type
MDR QMS
Legislation
MDR
Issue Date
March 30, 2023
Expiry Date
December 8, 2027
Revision
1

Certificate Lifecycle

March 30, 2023 December 8, 2027

Scopes

Quality Procedure Scope

Device Group Class IIa

R020101 - STANDARD BREATHING CIRCUITS R020102 - COAXIAL BREATHING CIRCUITS R020104 - CPAP AND NIV BREATHING CIRCUITS R020106 - IPPB CIRCUITS R020199 - BREATHING CIRCUITS AND KITS - OTHER R020201 - FIXED CATHETER MOUNTS R020202 - MOBILE CATHETER MOUNTS R020301 - RESPIRATORY CIRCUITS CONNECTION PIPES R020302 - RESPIRATORY CIRCUITS ADAPTERS AND CONNECTORS R020399 - ANESTHESIA AND RESUSCITATION CONNECTORS – OTHER R028001 - RESPIRATORY CIRCUITS VALVES R028003 - RESPIRATORY CIRCUITS WATER TRAPS R028099 - RESPIRATORY CIRCUITS AND MOUNT CATHETERS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES R030101 - VENTILATION MASKS R030102 - AIR/OXYGEN MASKS AND NASAL CANNULAS R030103 - AEROSOL THERAPY MASKS AND SYSTEMS R030202 - MANUALLY OPERATED VENTILATION BALLOONS R030280 - RESPIRATORY BALLONS - ACCESSORIES R040101 - ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS R040102 - ANTIBACTERIAL AND ANTIVIRAL RESPIRATORY FILTERS HUMIDIFIERS R040201 - TRACHEOSTOMY HUMIDIFIERS R060280 - HUMIDIFICATION SYSTEMS - ACCESSORIES R0680 - NEBULISATION AND HUMIDIFICATION SYSTEMS - ACCESSORIES NOT INCLUDED IN OTHER CLASSES R9001 - RESPIRATORY MOUTHPIECES

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.