EGZOTECH SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ

Certificate TNP/MDR/0015/4038/2023

Rev. Ver. 01Issued

Valid until: Nov 27, 2026

Certificate TNP/MDR/0015/4038/2023 — a Quality management system issued to EGZOTECH SPÓŁKA Z OGRANICZONĄ ODPOWIEDZIALNOŚCIĄ — is approaching its expiry. Valid until November 27, 2026. View the full certificate record on MD Atlas.

Overview

Certificate number: TNP/MDR/0015/4038/2023
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2274TNP/MDR/0015/4038/2023Ver. 01

Validity

Issued: Nov 28, 2023
Valid from: Nov 28, 2023
Valid until: Nov 27, 2026

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: 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 IIa4

4 scopes

Robot rehabilitacyjny / Rehabilitation Robots
Class IIa
Luna EMG
Class IIa
Meissa OT
Class IIa
Sidra LEG
Class IIa