UTECH Co., Ltd.

Certificate 7003GB448250805

Issued

Valid until: Nov 5, 2028

Certificate 7003GB448250805 is a valid Quality management system issued to UTECH Co., Ltd. and registered in EUDAMED. Valid until November 5, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 7003GB448250805
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 04827003GB448250805

Validity

Issued: Aug 5, 2025
Valid from: Aug 5, 2025
Valid until: Nov 5, 2028

Manufacturer

Manufacturer: UTECH Co., Ltd.
Manufacturer SRN: CN-MF-000002142
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0482
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: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb1

1 scope

MDA 0203 EMDN Z120302
Class IIb

Documents

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