Shanghai HeartCare Medical Technology Corporation Limited
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000001941 FEI 3024801436
- Devices
- 6
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
4 of 5 in force.
Market reach
- European Union
- EUDAMED actor, 5 certificates
- United States
- FDA FEI
- Authorised rep.
- Lotus NL B.V.NL
What Shanghai HeartCare Medical Technology Corporation Limited makes
Shanghai HeartCare Medical Technology Corporation Limited makes medical devices such as CAPTOR, which is a type of device that falls under the category of Class III devices.
The company's portfolio is regulated and listed in the eudamed registry, and the company is based in China.
Catalogue
Sealsac Ref ECS-3.5-12-3D-STD
Regimes: CE MDR Registry: EUDAMEDSealsac Ref ECS-7-12-3D-STD
Regimes: CE MDR Registry: EUDAMEDSealsac Ref ECS-8-30-3D-STD
Regimes: CE MDR Registry: EUDAMEDSealsac Ref ECS-6-12-HX-SS
Regimes: CE MDR Registry: EUDAMEDSealsac Ref ECS-2-3-HX-ES
Regimes: CE MDR Registry: EUDAMEDVasseal Ref VCD-VS-7F
Regimes: CE MDR Registry: EUDAMED
Company details
- EUDAMED SRN
- CN-MF-000001941
- FDA FEI number
- 3024801436
- EUDAMED status
- Active
- EUDAMED registered name
- Shanghai HeartCare Medical Technology Corporation Limited
- Registered address
- 590 Ruiqing Rd,Building 4,Suite 201,East Zhangjiang High-Tech Park, 201422, Shanghai, China
- Website
- www.heartcare.com.cn/
- [email protected]
- Phone
- +8618621683501
- PRRC contact
- Guohui Wang
EUDAMED certificates
5 certificates4 valid, 0 expired, 1 withdrawn or suspendedMDR 5next expiry 13 Nov 2028
UDEM Uluslararasi Belgelendirme Denetim Egitim Merkezi San. ve Tic. A.Ş. 2292 3 certificates
- MDR.2292-2026-0081 Active
Technical documentation EU MDR
- Issued
- 9 Oct 2026
- Expires
- 29 Sep 2031
- MDR.2292-2026/0064 Active
Quality management system EU MDR
- Issued
- 30 Sep 2026
- Expires
- 27 Aug 2031
- Reason
- Add device or group
- MDR.2292-2026/0065 Active
Technical documentation EU MDR
- Issued
- 16 Oct 2026
- Expires
- 27 Aug 2031
- Reason
- Other
UDEM Adriatic d.o.o. 2696 2 certificates
- M.2023.MDR.1027 Active
Quality management system EU MDR
- Issued
- 21 Aug 2026
- Expires
- 13 Nov 2028
- M.2023.MDR.1027-1 Withdrawn
Technical documentation EU MDR
- Issued
- 14 Nov 2023
- Expires
- 13 Nov 2026
- Reason
- Other
Frequently asked questions
How many devices does Shanghai HeartCare Medical Technology Corporation Limited have in the registry?
The registry currently lists 6 devices for Shanghai HeartCare Medical Technology Corporation Limited. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shanghai HeartCare Medical Technology Corporation Limited's devices?
Among its 6 most recently registered devices, Shanghai HeartCare Medical Technology Corporation Limited has devices listed in EUDAMED (6 devices).
What risk classes do Shanghai HeartCare Medical Technology Corporation Limited's devices fall under?
Among its 6 most recently registered devices, the classes recorded for Shanghai HeartCare Medical Technology Corporation Limited's devices are Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Shanghai HeartCare Medical Technology Corporation Limited?
EUDAMED lists 5 certificates for Shanghai HeartCare Medical Technology Corporation Limited (technical documentation; quality management system) under MDR. 2 are recorded with the status issued. The most recent was issued on 16 Oct 2026.
What are the newest devices from Shanghai HeartCare Medical Technology Corporation Limited in the registry?
The most recently registered devices listed for Shanghai HeartCare Medical Technology Corporation Limited include SEALSAC and VASSEAL.