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Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

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Jiangsu Enjosim Medical Technology Co., Ltd.

Certificate 6253932CE01

Rev. 0Issued
Valid until
Mar 1, 2031

Certificate 6253932CE01 is a valid Quality management system issued to Jiangsu Enjosim Medical Technology Co., Ltd. and registered in EUDAMED. Valid until March 1, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number
6253932CE01
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
03446253932CE010

Validity

Issued
Mar 13, 2026
Valid from
Mar 13, 2026
Valid until
Mar 1, 2031

Notified body

Notified body
DEKRA Certification B.V.
Notified body SRN
0344
Notified body country
Netherlands

Characteristics

Sterile
No
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 IIb1

1 scope

  • DEVICE
    Class IIb

Documents

LanguagesEN

Manufacturer

Manufacturer
Jiangsu Enjosim Medical Technology Co., Ltd.
Manufacturer SRN
CN-MF-000045016
Manufacturer country
China

Covered devices

  • Pen InjectorClass IIb
    697663472KXCF-01ABV