Basic UDI-DIs
0
Scopes
2
Preceding Certs
0
Risk Classes
2
Characteristics
1
Revision
0
364
Valid for 364 days
Expiry: June 8, 2027
Basic Information
- Number
- HZ 2309178-1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- November 21, 2022
- Expiry Date
- June 8, 2027
- Manufacturer
- Tianjin Medis Medical Device Co., Ltd.
Certificate Lifecycle
Today
November 21, 2022
June 8, 2027
Device Characteristics
Sterile
Scopes
2 scopes covering 2 risk classes
Quality Procedure Scope
Device Group
Class IIa
R010301 - ENDOTRACHEAL TUBES, CUFFLESS R010302 - ENDOTRACHEAL TUBES, CUFFED R010501 - TRACHEOSTOMY AND LARINGECTOMY CANNULAS AND KITS, UNCUFFED R010502 - TRACHEOSTOMY AND LARINGECTOMY CANNULAS AND KITS, CUFFED R010401 - ENDOBRONCHIAL TUBES, RIGHT R010402 - ENDOBRONCHIAL TUBES, LEFT R010201 - LARYNGEAL MASKS
Quality Procedure Scope
Device Group
Class I
Sterile
R010101 - NASOPHARYNGEAL TUBES R010380 - ENDOTRACHEAL TUBES - ACCESSORIES
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.