Vcomin Technology Limited
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000039445 FEI 3017195985
- Devices
- 5
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
- Authorised rep.
- Shanghai International Holding Corp. GmbH(Europe)DE
What Vcomin Technology Limited makes
Vcomin Technology Limited manufactures handheld fetal Doppler devices, including models such as the FD-231B, FD-640D, and FD-200B. These devices are designed for non-invasive prenatal monitoring of fetal heart rate and blood flow, commonly used in clinical and home settings.
The company’s fetal Doppler devices are classified as Class II and Class IIa medical devices. They are registered in the EU’s euamed database and listed under the FDA’s 510(k) premarket notification process. The manufacturer is based in China.
Catalogue
Fetal Doppler Ref FD-290B
CE MDR EUDAMEDFetal Doppler Ref FD-530B
CE MDR EUDAMEDFetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D) Ref K182526
CE MDR 510(k) 510(k)Fetal Doppler Ref FD-530G
CE MDR EUDAMEDFetal Doppler Ref FD-540B
CE MDR EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000039445
- FDA FEI number
- 3017195985
- EUDAMED status
- Active
- EUDAMED registered name
- Vcomin Technology Limited
- Registered address
- 2&3 FI., No1,Kangzheng.Rd.,Buji Town 518110 Shenzhen PEOPLE'S REPUBLIC OF CHINA, 518110, Shenzhen, China
- Website
- www.vcomin.com
- [email protected]
- PRRC contact
- Han Jielin
From the company website
SHENZHEN WEI KANG MING TECHNOLOGY LTD. WAS FOUNDED IN 2009 AS A PROFESSIONAL ENTERPRISE IN HIGH-TECH MEDICAL EQUIPMENT THAT COMBINES RESEARCH AND DEVELOPMENT, PRODUCTION, MARKETING AND SERVICES. THE COMPANY HAS A MODERN PRODUCTION AREA OF MORE THAN 2,000 SQUARE METRES AND COMPLETE STATE-OF-THE-ART FACILITIES, FULLY AND RIGOROUSLY IMPLEMENTING AN INTERNATIONAL QUALITY MANAGEMENT SYSTEM THAT PROVIDES HIGH-QUALITY MEDICAL PRODUCTS GLOBALLY. IN KEEPING WITH THE BUSINESS PHILOSOPHY OF “MANUFACTURING QUALITY PRODUCTS TO PROVIDE SATISFACTORY SERVICES” AND THE BUSINESS CULTURE OF “PROFESSIONAL, HONEST AND EFFICIENT”, WIKANG MING IS COMMITTED TO THE DEVELOPMENT OF HEALTH CARE AND HYGIENE. WITH A SPIRIT OF INNOVATION AND EXCELLENCE, ADVANCED TECHNOLOGY, EXCELLENT QUALITY AND EXCELLENT AFTER-SALES SERVICES, COMPANIES RAPIDLY GROW INTO LEADING FIRMS IN THE SAME INDUSTRY. THROUGH THE TUVISO 13485 PRODUCT QUALITY SYSTEM IN GERMANY, THE COMPANY CERTIFIED THE PRODUCT THROUGH THE EC. AT PRESENT, THE VECOMIN DOPPLER GYMNASIUM, CARDIOGRAPHER, FETAL MONITOR, BLOOD FLOWER, ANIMAL DOPPLER BLOOD PRESSURE SYSTEM PRODUCTS HAVE BEEN SOLD TO MORE THAN 90 COUNTRIES AND TERRITORIES AND ARE WIDELY APPRECIATED BY CLIENTS. WICONMING HAS A GOOD RESEARCH AND DEVELOPMENT TEAM. OUR RESEARCH AND DEVELOPMENT STAFF COME FROM KEY UNIVERSITIES IN THE COUNTRY, WITH MORE THAN 50 PER CENT OF THEM HAVING MASTER'S DEGREES AND ABOVE, AND ACTIVELY COOPERATE WITH WELL-KNOWN UNIVERSITIES IN THE COUNTRY. THE WIKANG MING TEAM FOCUSES ON INDUSTRY TECHNOLOGY AND IS CONSTANTLY DEVELOPING INNOVATIONS TO BUILD FIRST-CLASS PRODUCTS. THE COMPANY ' S HIGHLY QUALIFIED MARKETING TALENT, BUSINESS MANAGEMENT TALENT AND AFTER-SALES SERVICE TEAMS ENSURE EFFICIENT, ROBUST AND HEALTHY BUSINESS DEVELOPMENT. THE COMPANY ' S WELL-DEVELOPED SYSTEM OF DOMESTIC AND FOREIGN SALES AND SERVICES PROVIDES HIGH-QUALITY PRODUCTS AND SERVICES TO ITS CLIENTS. VECONMING PRODUCTS HAVE SERVED MANY HOSPITALS AND FAMILIES AROUND THE WORLD. THE EXCELLENCE OF QUALITY, PREFERENTIAL PRICES AND GENUINE SERVICES HAVE ENABLED US TO GAIN INCREASING CLIENT COOPERATION AND TRUST. WEI'S MISSION WILL BE TO PROVIDE HIGH-QUALITY MEDICAL PRODUCTS THAT SERVE THE HEALTH OF THE GENERAL POPULATION, TO CONSTANTLY DEVELOP AND INNOVATE, AND TO CONTRIBUTE IN GOOD FAITH TO A WIDE RANGE OF USERS AT HOME AND ABROAD。
Frequently asked questions
How many devices does Vcomin Technology Limited have in the registry?
The registry currently lists 5 devices for Vcomin Technology Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Vcomin Technology Limited's devices?
Among its 5 most recently registered devices, Vcomin Technology Limited 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 Vcomin Technology Limited's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Vcomin Technology Limited's devices are Class IIa and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Vcomin Technology Limited in the registry?
The most recently registered devices listed for Vcomin Technology Limited include Fetal Doppler and Fetal Doppler (Models: FD-231B, FD-231D, FD-640B, FD-640D, FD-200B, FD-200D, FD-591B, and FD-591D).