Hangzhou Singclean Medical Products Co., Ltd.

Certificate 10000471388-PA-NoMA-CHN

Rev. 1Issued

Valid until: Apr 17, 2028

Certificate 10000471388-PA-NoMA-CHN is a valid Quality management system issued to Hangzhou Singclean Medical Products Co., Ltd. and registered in EUDAMED. Valid until April 17, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 10000471388-PA-NoMA-CHN
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 246010000471388-PA-NoMA-CHN1

Validity

Issued: Apr 17, 2023
Valid from: Apr 17, 2023
Valid until: Apr 17, 2028

Notified body

Notified body: DNV Product Assurance AS
Notified body SRN: 2460
Notified body country: Norway

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: Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class III2

2 scopes

Medical Sodium Hyaluronate Gel for Anti-adhesion. The product is indicated for helping to prevent or reduce postoperative adhesions after abdominal and pelvic surgery.
Class III
DEVICE
Class III

Documents

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