UNITRA Sp. z o.o.

Certificate TNP/MDR/0023/5338/2024

Rev. Ver. 01Issued

Valid until: Sep 2, 2027

Certificate TNP/MDR/0023/5338/2024 is a valid Quality management system issued to UNITRA Sp. z o.o. and registered in EUDAMED. Valid until September 2, 2027. View the full certificate record on MD Atlas.

Overview

Certificate number: TNP/MDR/0023/5338/2024
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2274TNP/MDR/0023/5338/2024Ver. 01

Validity

Issued: Sep 3, 2024
Valid from: Sep 3, 2024
Valid until: Sep 2, 2027

Notified body

Notified body: TUV NORD Polska Sp. z o.o
Notified body SRN: 2274
Notified body country: Poland

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: 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

Urządzenie wspomagające manualną resuscytację / Device supporting manual resuscitation
Class IIb
Breath
Class IIb