SpofaDental a.s.

Certificate 44911240240

Rev. 1Issued

Valid until: May 10, 2031

Certificate 44911240240 is a valid Quality management system issued to SpofaDental a.s. and registered in EUDAMED. Valid until May 10, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: 44911240240
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0044449112402401

Validity

Issued: May 11, 2026
Valid from: May 11, 2026
Valid until: May 10, 2031

Manufacturer

Manufacturer: SpofaDental a.s.
Manufacturer SRN: CZ-MF-000000945
Manufacturer country: Czechia

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: 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 IIa1

1 scope

MDN 1103, Non-active dental implants and dental materials; EMDN: Q0101010299: TEMPORARY AND PERMANENT DENTAL RESTORATION CEMENTS - OTHER
Class IIa

Documents

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