Basic UDI-DIs
0
Scopes
3
Preceding Certs
0
Risk Classes
3
Characteristics
1
Revision
0
485
Valid for 485 days
Expiry: October 6, 2027
Basic Information
- Number
- HZ 2186867-1
- Type
- MDR QMS
- Legislation
- MDR
- Issue Date
- October 26, 2022
- Expiry Date
- October 6, 2027
- Manufacturer
- Zhejiang Top-medical Medical Dressing Co., Ltd.
Certificate Lifecycle
Today
October 26, 2022
October 6, 2027
Device Characteristics
Sterile
Scopes
3 scopes covering 3 risk classes
Quality Procedure Scope
Device Group
Class IIa
M04040301 - HYDROCOLLOID DRESSINGS, NON-COMBINED M04040201 - ALGINATE DRESSINGS, NON-COMBINED M04040601 - POLYURETHANE DRESSINGS, NON-COMBINED A06010101 - DRAINAGE SYSTEMS WITH PREDEFINED SUCTION
Quality Procedure Scope
Device Group
Class IIb
M04040701- SILICONE DRESSINGS, NON-COMBINED
Quality Procedure Scope
Device Group
Class I
Sterile
M040101 - ADHESIVE DRESSINGS, WITH ABSORBENT PAD T02010101 - INCISION DRAPES, WITHOUT ANTIBACTERIAL AGENT
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.