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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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United Dental Changzhou

Certificate DZ 2138755-1

Rev. 0Issued
Valid until
Jun 27, 2028

Certificate DZ 2138755-1 is a valid Quality assurance issued to United Dental Changzhou and registered in EUDAMED. Valid until June 27, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number
DZ 2138755-1
Certificate type
Quality assurance
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
0197DZ 2138755-10

Validity

Issued
Jun 28, 2023
Valid from
Jun 28, 2023
Valid until
Jun 27, 2028

Notified body

Notified body
TÜV Rheinland LGA Products GmbH
Notified body SRN
0197
Notified body country
Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile
Yes
Human tissues
No
Animal tissues
No
In vitro diagnostics
No
Initial registration
Yes
New device
No
Discard allowed
No
SSCP enabled
Yes
Mechanism of scrutiny
No
Intended medical purpose
No
SPP applicable
No
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa1Class I1

2 scopes

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

Documents

LanguagesEN

Manufacturer

Manufacturer
United Dental Changzhou
Manufacturer SRN
CN-MF-000018453
Manufacturer country
China