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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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E. HAHNENKRATT GmbH

Certificate HZ 1105628-1

Rev. 0Issued
Valid until
Jul 5, 2027

Certificate HZ 1105628-1 is a valid Quality management system issued to E. HAHNENKRATT GmbH and registered in EUDAMED. Valid until July 5, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number
HZ 1105628-1
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
0197HZ 1105628-10

Validity

Issued
Sep 2, 2022
Valid from
Sep 2, 2022
Valid until
Jul 5, 2027

Manufacturer

Manufacturer
E. HAHNENKRATT GmbH
Manufacturer SRN
DE-MF-000007184
Manufacturer country
Germany

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 IIa2

2 scopes

  • Q010199 - CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES-OTHER
    Class IIa
  • Q010102 - ROOT CANAL FILLING DEVICES
    Class IIa

Documents

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