DÜRR DENTAL SE

Certificate 1000275872

Rev. 07Supplemented

Valid until: Mar 10, 2027

Certificate 1000275872 is a valid Quality management system issued to DÜRR DENTAL SE and registered in EUDAMED. Valid until March 10, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: 1000275872
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0297100027587207

Validity

Issued: Mar 27, 2026
Valid from: Mar 27, 2026
Valid until: Mar 10, 2027

Notified body

Notified body: DQS Medizinprodukte GmbH
Notified body SRN: 0297
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: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: No
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

170778794Quality management systemIssuedMar 11, 2022 → Mar 10, 2027

Scope coverage

Class IIa19Class IIb5

24 scopes

MDA 0204 - Other active non-implantable devices for monitoring and/or diagnosis
Class IIa
MDA 0311 - Active non-implantable dental devices
Class IIa
MDA 0315 - Software
Class IIb
MDN 1202 - Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
Class IIa
MDA 0317 – Active non-implantable devices for cleaning, disinfection and sterilisation
Class IIa
MDN 1207 - Non-active non-implantable diagnostic devices
Class IIa
EMDN Z11031192 - SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - MEDICAL DEVICE SOFTWARE
Class IIb
EMDN Z11031101 - MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
Class IIb
Intraoral Sensors
Class IIa
Compressors for dental applications
Class IIa
Suction machines for dental applications
Class IIa
Clinic pressure stations for dental applications
Class IIa
Clinic suction stations for dental applications
Class IIa
Mobile suction machines for dental applications
Class IIa
Powder jet devices and single use tips for dental applications
Class IIa
Ultrasonic devices for dental applications
Class IIa
System consisting of compressor and suction machine for dental applications
Class IIa
Imaging Software for dental applications
Class IIa
Suction cannulas
Class IIa
Surgical cannulas for single use
Class IIa

1 / 2

Documents

LanguagesDEEN

Scope coverage

Class IIa19Class IIb5

24 scopes

MDA 0204 - Other active non-implantable devices for monitoring and/or diagnosis
Class IIa
MDA 0311 - Active non-implantable dental devices
Class IIa
MDA 0315 - Software
Class IIb
MDN 1202 - Non-active non-implantable devices for administration, channelling and removal of substances, including devices for dialysis
Class IIa
MDA 0317 – Active non-implantable devices for cleaning, disinfection and sterilisation
Class IIa
MDN 1207 - Non-active non-implantable diagnostic devices
Class IIa
EMDN Z11031192 - SYSTEMS FOR DIRECT DIGITAL RADIOLOGY (DR) - MEDICAL DEVICE SOFTWARE
Class IIb
EMDN Z11031101 - MULTIFUNCTIONAL SYSTEMS FOR DIRECT DIGITAL RADIOLOGY
Class IIb
Intraoral Sensors
Class IIa
Compressors for dental applications
Class IIa
Suction machines for dental applications
Class IIa
Clinic pressure stations for dental applications
Class IIa
Clinic suction stations for dental applications
Class IIa
Mobile suction machines for dental applications
Class IIa
Powder jet devices and single use tips for dental applications
Class IIa
Ultrasonic devices for dental applications
Class IIa
System consisting of compressor and suction machine for dental applications
Class IIa
Imaging Software for dental applications
Class IIa
Suction cannulas
Class IIa
Surgical cannulas for single use
Class IIa

1 / 2

Certificate 1000275872

Overview

Validity

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Certificate 1000275872

Overview

Validity

Manufacturer

Notified body

Covered devices

Characteristics

History

Status changes

Supersedes

Scope coverage

Documents

Manufacturer