Smart Labs Spółka z ograniczoną odpowiedzialnością

Certificate HZ 2297231-1

Rev. 0Cancelled

Valid until: Aug 29, 2028

Certificate HZ 2297231-1, a Quality management system issued to Smart Labs Spółka z ograniczoną odpowiedzialnością, has been withdrawn. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2297231-1
Certificate type: Quality management system
Certificate status: Cancelled
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 2297231-10

Validity

Issued: Aug 30, 2023
Valid from: Aug 30, 2023
Valid until: Aug 29, 2028

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
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: No
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

Status changes

Cancelled

Supersedes

HZ 2297231-1Quality management systemIssuedAug 30, 2023 → Aug 29, 2028

Scope coverage

Class IIa1

1 scope

Z129092 – VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS - MEDICAL DEVICE SOFTWARE
Class IIa

Documents

LanguagesEN