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Jiangsu Sunride Medical Technology Co., Ltd.

Certificate IT351984

Rev. 1Issued
Valid until
Apr 26, 2031

Certificate IT351984 is a valid Quality management system issued to Jiangsu Sunride Medical Technology Co., Ltd. and registered in EUDAMED. Valid until April 26, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number
IT351984
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
1370IT3519841

Validity

Issued
Apr 27, 2026
Valid from
Apr 27, 2026
Valid until
Apr 26, 2031

Notified body

Notified body
BUREAU VERITAS ITALIA S.P.A.
Notified body SRN
1370
Notified body country
Italy

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
No
Intended medical purpose
No
SPP applicable
No
Conditions applicable
Yes
MOS outside EUDAMED
—
QMS/MOS type
Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I4Class IIa4

8 scopes

  • Drainage Bag
    Class I
  • Negative pressure drainage ball
    Class I
  • Disposable Drainage kit XFCX
    Class IIa
  • Disposable Drainage kit XFYL
    Class IIa
  • DEVICE
    Class I
  • DEVICE
    Class I
  • DEVICE
    Class IIa
  • DEVICE
    Class IIa

Documents

LanguagesEN

Manufacturer

Manufacturer
Jiangsu Sunride Medical Technology Co., Ltd.
Manufacturer SRN
CN-MF-000040642
Manufacturer country
China

Covered devices

  • Drainage bagClass I
    69407779XFYD4A
  • Negative pressure drainage ballClass I
    69407779XFYD-Q5S
  • Disposable drainage kitClass IIa
    69407779XFCX3G
  • Disposable drainage kitClass IIa
    69407779XFYL4S