F Care Systems

Certificate MDR-0025

Rev. 1Issued

Valid until: Jan 27, 2030

Certificate MDR-0025 is a valid Quality management system issued to F Care Systems and registered in EUDAMED. Valid until January 27, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR-0025
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1304MDR-00251

Validity

Issued: Jan 28, 2025
Valid from: Jan 28, 2025
Valid until: Jan 27, 2030

Notified body

Notified body: SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
Notified body SRN: 1304
Notified body country: Slovenia

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
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

Gastrointestinal haemostasis devices - other
Class IIb
Haemorrhoid probes
Class IIb

Documents

LanguagesEN