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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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MD Atlas
Documents

DIPLOMAT DENTAL s.r.o.

Certificate 2025-MDR/QS-056

Rev. 0Issued

Valid until: Nov 21, 2030

Overview

Certificate number: 2025-MDR/QS-056
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 22652025-MDR/QS-0560

Validity

Issued: Nov 21, 2025
Valid from: Nov 21, 2025
Valid until: Nov 21, 2030

Manufacturer

Manufacturer: DIPLOMAT DENTAL s.r.o.
Manufacturer SRN: SK-MF-000002562
Manufacturer country: Slovakia

Notified body

Notified body: 3EC International a.s.
Notified body SRN: 2265
Notified body country: Slovakia

Covered devices

Dental unitsClass IIa
8588007067DENTALUNITK505C

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: Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

DENTAL TREATMENT UNITS
Class IIa
DEVICE
Class IIa

Documents

LanguagesENSK