X-Tech Medical Ltd

Certificate GB25/000009

Rev. 1Issued

Valid until: Jan 14, 2030

Certificate GB25/000009 is a valid Quality management system issued to X-Tech Medical Ltd and registered in EUDAMED. Valid until January 14, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: GB25/000009
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 1639GB25/0000091

Validity

Issued: Jan 14, 2025
Valid from: Jan 14, 2025
Valid until: Jan 14, 2030

Manufacturer

Manufacturer: X-Tech Medical Ltd
Manufacturer SRN: GB-MF-000021768
Manufacturer country: United Kingdom

Notified body

Notified body: SGS Belgium NV
Notified body SRN: 1639
Notified body country: Belgium

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: No
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 I4

4 scopes

MDN1201 MDS1005
Class I
Sterile inlet seal for use in endoscopic procedures
Class I
Sterile tracheal tube introducers (bougies)
Class I
Sterile irrigation tap for use in endoscopic procedures
Class I

Documents

LanguagesEN