3BFAB TEKNOLOJI ANONIM ŞIRKETI

Certificate MDR.2292-2025/0032

Rev. 0Issued

Valid until: Dec 17, 2030

Certificate MDR.2292-2025/0032 is a valid Quality assurance issued to 3BFAB TEKNOLOJI ANONIM ŞIRKETI and registered in EUDAMED. Valid until December 17, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR.2292-2025/0032
Certificate type: Quality assurance
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2292MDR.2292-2025/00320

Validity

Issued: Dec 18, 2025
Valid from: Dec 18, 2025
Valid until: Dec 17, 2030

Notified body

Notified body: UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş.
Notified body SRN: 2292
Notified body country: Türkiye

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

PERMANENT CROWN RESIN
Class IIa
PERMANENT CROWN RESIN
Class IIa

Documents

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