Jiangsu Enjosim Medical Technology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000045016
- Devices
- 5
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
Catalogue
Disposable Pen Injector (KXYC-03C02) Ref K253747
Regimes: 510(k) Registry: 510(k)Pen Injector Ref KXCF-02B
Regimes: CE MDR Registry: EUDAMEDPen Injector Ref KXCF-02A
Regimes: CE MDR Registry: EUDAMEDPen Injector Ref KXCF-01B
Regimes: CE MDR Registry: EUDAMEDPen Injector Ref KXCF-01A
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000045016
- EUDAMED status
- Active
- EUDAMED registered name
- Jiangsu Enjosim Medical Technology Co., Ltd.
- Registered address
- No.96, Dong'an Road, Anzhen, Xishan District, WuXi City, Jiangsu Province, China, 214104, Wuxi City, China
- Website
- www.enjosimmedical.com
- [email protected]
- Phone
- +86 0510 8866 8891
- PRRC contact
- Ju Hu
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 1 Mar 2031
DEKRA Certification B.V. 0344 1 certificate
- 6253932CE01 Active
Quality management system EU MDR
- Issued
- 13 Mar 2026
- Expires
- 1 Mar 2031
Frequently asked questions
How many devices does Jiangsu Enjosim Medical Technology Co., Ltd. have in the registry?
The registry currently lists 5 devices for Jiangsu Enjosim Medical Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Jiangsu Enjosim Medical Technology Co., Ltd.'s devices?
Among its 5 most recently registered devices, Jiangsu Enjosim Medical Technology Co., Ltd. has devices listed in EUDAMED (4 devices) and FDA 510(k) (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Jiangsu Enjosim Medical Technology Co., Ltd.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Jiangsu Enjosim Medical Technology Co., Ltd.'s devices are Class IIb and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Jiangsu Enjosim Medical Technology Co., Ltd.?
EUDAMED lists 1 certificate for Jiangsu Enjosim Medical Technology Co., Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 13 Mar 2026.
What are the newest devices from Jiangsu Enjosim Medical Technology Co., Ltd. in the registry?
The most recently registered devices listed for Jiangsu Enjosim Medical Technology Co., Ltd. include Disposable Pen Injector (KXYC-03C02) and Pen Injector.