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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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Drendel + Zweiling DIAMANT GmbH

Certificate HZ 1461197-1

Rev. 0Issued
Valid until
May 9, 2028

Certificate HZ 1461197-1 is a valid Quality management system issued to Drendel + Zweiling DIAMANT GmbH and registered in EUDAMED. Valid until May 9, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number
HZ 1461197-1
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
0197HZ 1461197-10

Validity

Issued
May 10, 2023
Valid from
May 10, 2023
Valid until
May 9, 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
No
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 IIa3

3 scopes

  • L090999 - Orthopedic Surgery Cutting Instruments, Reusable - Other
    Class IIa
  • Q010199 - Conservative Dentistry And Endodontics Devices - Other
    Class IIa
  • Q010399 - Surgical Dental Devices - Other
    Class IIa

Documents

LanguagesEN

Manufacturer

Manufacturer
Drendel + Zweiling DIAMANT GmbH
Manufacturer SRN
DE-MF-000006449
Manufacturer country
Germany