TBF Global Med. GmbH

Certificate 6QMS-MDR-0075/07/2025

Rev. 00Issued

Valid until: Jul 1, 2030

Certificate 6QMS-MDR-0075/07/2025 is a valid Quality management system issued to TBF Global Med. GmbH and registered in EUDAMED. Valid until July 1, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 6QMS-MDR-0075/07/2025
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 27646QMS-MDR-0075/07/202500

Validity

Issued: Jul 2, 2025
Valid from: Jul 2, 2025
Valid until: Jul 1, 2030

Notified body

Notified body: Notice Belgelendirme, Muayene ve Denetim Hizmetleri Anonim Şirketi
Notified body SRN: 2764
Notified body country: Türkiye

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: Yes
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: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

Sterile Viscoelastic OVD (Ophthalmic Viscosurgical Device) // Varyants 1mL, 2mL, 3mL
Class IIb
Sterile Viscoelastic OVD (Ophthalmic Viscosurgical Device)
Class IIb

Documents

LanguagesEN