MDR MDR QA Issued

DZ 2138755-1

Manufacturer: United Dental Changzhou
Basic UDI-DIs
0
Scopes
2
Preceding Certs
0
Risk Classes
2
Characteristics
1
Revision
0

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702
Valid for 702 days
Expiry: June 27, 2028

Basic Information

Number
DZ 2138755-1
Type
MDR QA
Legislation
MDR
Issue Date
June 28, 2023
Expiry Date
June 27, 2028

Certificate Lifecycle

June 28, 2023 June 27, 2028

Device Characteristics

Sterile

Scopes

2 scopes covering 2 risk classes

Quality Procedure Scope

Device Group Class IIa

Q010507 - ENDODONTIC INSTRUMENTS (CANAL ENLARGERS, FILES, RASPS, ETC.), SINGLE-USE L159004 - ENDODONTIC RASPS AND FILES, REUSABLE

Quality Procedure Scope

Device Group Class I Reusable Surgical Instrument

L159004 - ENDODONTIC RASPS AND FILES, REUSABLE

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.