Wilson Instruments (SHA) Co., Ltd.

Certificate HZ 2186769-1

Rev. 0Issued

Valid until: Oct 28, 2030

Certificate HZ 2186769-1 is a valid Quality management system issued to Wilson Instruments (SHA) Co., Ltd. and registered in EUDAMED. Valid until October 28, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2186769-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2186769-10

Validity

Issued: Oct 29, 2025
Valid from: Oct 29, 2025
Valid until: Oct 28, 2030

Manufacturer

Manufacturer: Wilson Instruments (SHA) Co., Ltd.
Manufacturer SRN: CN-MF-000013732
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0197
Notified body country: Germany

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I1Class IIa1Class IIb1

3 scopes

G030501 - DIGESTIVE ENDOSCOPY, RETRIEVAL DEVICES G030803 - GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BRUSHES G0380 - DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES G030804 - GASTROINTESTINAL ENDOSCOPY AND ECHOENDOSCOPY, BITE BLOCKS G0399 - DIGESTIVE ENDOSCOPY DEVICES - OTHER
Class I
G030801 - GASTROINTESTINAL ENDOSCOPY, FORCEPS, SINGLE-USE G030201 - DIGESTIVE ENDOSCOPY, NEEDLES G0380 - DIGESTIVE ENDOSCOPY DEVICES - ACCESSORIES
Class IIa
G030301 - POLYPECTOMY DEVICES POLYPECTOMY SNARES
Class IIb

Documents

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