Wuxi Hisky Medical Technologies Co., Ltd.

Certificate 292/MDR

Rev. 1Issued

Valid until: May 21, 2031

Certificate 292/MDR is a valid Quality management system issued to Wuxi Hisky Medical Technologies Co., Ltd. and registered in EUDAMED. Valid until May 21, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: 292/MDR
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0051292/MDR1

Validity

Issued: May 22, 2026
Valid from: May 22, 2026
Valid until: May 21, 2031

Manufacturer

Manufacturer: Wuxi Hisky Medical Technologies Co., Ltd.
Manufacturer SRN: CN-MF-000022547
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0051
Notified body country: Italy

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa1

1 scope

Dispositivo per l'imaging microscopico confocale dei tessuti corporei durante procedure diagnostiche e terapeutiche e relativi accessori / Device for confocal microscopic imaging of body tissues during diagnostic and therapeutic procedures and related accessories
Class IIa

Documents

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