eSonic Technology (Wuhan) Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000040930
- Devices
- 2
- Registrations
- EUDAMED
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
What eSonic Technology (Wuhan) Co., Ltd. makes
eSonic Technology (Wuhan) Co., Ltd. manufactures diagnostic ultrasound systems under the eHertz Functional Series, including models eHertz C, eHertz E, eHertz R, and eHertz S. These devices are designed for medical imaging to visualize internal body structures using high-frequency sound waves, supporting diagnostic evaluations in clinical settings.
The eHertz Functional Series diagnostic ultrasound systems fall under Class II regulatory classification. They are listed in the FDA’s 510(k) registry, indicating their compliance with U.S. medical device regulations. The company is based in China.
Catalogue
- 510(k) 510(k)
eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S) Ref K250228
CE MDR 510(k) EUDAMED510(k)
Company details
- EUDAMED SRN
- CN-MF-000040930
- EU VAT number
- 91420100MAC1H58B72
- EUDAMED status
- Active
- EUDAMED registered name
- eSonic Technology (Wuhan) Co., Ltd.
- Registered address
- Floor 7, Building B1, Block B, Phase II, High-tech Medical Devices Park, No.818 Gaoxin Avenue, East Lake High-tech Development Zone, Wuhan, Hubei, China, 430206, Wuhan, Hubei, China
- [email protected]
- PRRC contact
- Dongyun Guo
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 14 Dec 2030
TÜV Rheinland LGA Products GmbH 0197 1 certificate
- HZ 2505250-1 Issued
Quality management system EU MDR
- Issued
- 15 Dec 2025
- Expires
- 14 Dec 2030
Frequently asked questions
How many devices does eSonic Technology (Wuhan) Co., Ltd. have in the registry?
The registry currently lists 2 devices for eSonic Technology (Wuhan) Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list eSonic Technology (Wuhan) Co., Ltd.'s devices?
Among its 2 most recently registered devices, eSonic Technology (Wuhan) Co., Ltd. has devices listed in EUDAMED (1 device) and FDA 510(k) (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do eSonic Technology (Wuhan) Co., Ltd.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for eSonic Technology (Wuhan) Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for eSonic Technology (Wuhan) Co., Ltd.?
EUDAMED lists 1 certificate for eSonic Technology (Wuhan) Co., Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 2025-12-15.
What are the newest devices from eSonic Technology (Wuhan) Co., Ltd. in the registry?
The most recently registered devices listed for eSonic Technology (Wuhan) Co., Ltd. include ePascal S/ ePascal SOR/ ePascal S5/ ePascal SA/ ePascal SE/ ePascal 80Elite/ ePascal 80/ MOZI-X1/ MOZI-X12/ DF-41E Diagnostic ultrasound system and eHertz Functional Series Diagnostic Ultrasound System (eHertz C, eHertz E, eHertz R, eHertz S).