Dreve Dentamid GmbH

Certificate 44911220477

Rev. 2Supplemented

Valid until: Dec 4, 2028

Overview

Certificate number: 44911220477
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0044449112204772

Validity

Issued: Apr 19, 2024
Valid from: Apr 19, 2024
Valid until: Dec 4, 2028

Manufacturer

Manufacturer: Dreve Dentamid GmbH
Manufacturer SRN: DE-MF-000005452
Manufacturer country: Germany

Notified body

Notified body: TÜV NORD CERT GmbH
Notified body SRN: 0044
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: No
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: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

44911220477Quality management systemIssuedDec 15, 2023 → Dec 4, 2028

Scope coverage

Class IIa2

2 scopes

MDN 1103: Provisorisches Zahnmaterial Dentamid
Class IIa
MDN 1209: Abformsilikon Dentamid, Bissregistrat Dentamid, Dentales Schienungsmaterial (langzeit), Dentales Schienungsmaterial 3D-Druck, Elasto-Positioner Dentamid, FotoDent Kunststoffe Bohrschablone 3D-Druck Klasse IIa (chirurgisch), FotoDent Kunststoffe Prothesenbase 3D-Druck, Lichthärtende Lacke Klasse IIa Dentamid, Prothesengießkunststoff Dentamid, Unterfütterungssilikon Dentamid
Class IIa

Documents

LanguagesEN

Dreve Dentamid GmbH

Certificate 44911220477

Rev. 2Supplemented

Valid until: Dec 4, 2028

Overview

Certificate number: 44911220477
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0044449112204772

Validity

Issued: Apr 19, 2024
Valid from: Apr 19, 2024
Valid until: Dec 4, 2028

Manufacturer

Manufacturer: Dreve Dentamid GmbH
Manufacturer SRN: DE-MF-000005452
Manufacturer country: Germany

Notified body

Notified body: TÜV NORD CERT GmbH
Notified body SRN: 0044
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: No
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: No
QMS/MOS type: Others

History

Status changes

Supplemented

Supersedes

44911220477Quality management systemIssuedDec 15, 2023 → Dec 4, 2028

Scope coverage

Class IIa2

2 scopes

MDN 1103: Provisorisches Zahnmaterial Dentamid
Class IIa
MDN 1209: Abformsilikon Dentamid, Bissregistrat Dentamid, Dentales Schienungsmaterial (langzeit), Dentales Schienungsmaterial 3D-Druck, Elasto-Positioner Dentamid, FotoDent Kunststoffe Bohrschablone 3D-Druck Klasse IIa (chirurgisch), FotoDent Kunststoffe Prothesenbase 3D-Druck, Lichthärtende Lacke Klasse IIa Dentamid, Prothesengießkunststoff Dentamid, Unterfütterungssilikon Dentamid
Class IIa

Documents

LanguagesEN