EUDAMED registration D-9100052XDYesShear Wave Quantificational Ultrasound Diagnostic System
- Risk class
- Class IIa
- CND nomenclatures code
- Z12040103
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- D-9100052XD
- Basic UDI
- B-9100052XD
- Version date
- October 25, 2022
- Manufacturer last update
- October 25, 2022
- Active status
- Yes
- Manufacturer name
- Wuxi Hisky Medical Technologies Co., Ltd.
- Country
- China
- Country type
- NON_EU
- Address
- Room B401, 530 Plaza, University Science Park, Taihu International Science & Technology Park 214135 Wuxi, Jiangsu Province
- ra@hiskymedical.com
- SRN
- DE-AR-000000001
- Country
- Germany
- Address
- 80 Eiffestraße Hamburg
- shholding@hotmail.com
- Telephone
- +49 40 2513175
- Competent authority
- DE/CA05 - Behorde fur Justiz und Verbraucherschutz
- Applicable legislation
- MDD (Directive 93/42/EEC on Medical Devices)
- Placed on the market
- Hungary
- Market available
- Hungary:2019-08-28~2022-05-30
- Human tissues
- No
- Animal tissues
- No
HEPATIC FUNCTIONALITY EQUIPMENT
Access comprehensive regulatory information for Shear Wave Quantificational Ultrasound Diagnostic System in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI D-9100052XD and manufactured by Wuxi Hisky Medical Technologies Co., Ltd. in China.
This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA05 - Behorde fur Justiz und Verbraucherschutz), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.