Shanghai Handy Medical Equipment Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000030072 FEI 3013039893
- Devices
- 23
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
EU certificates
1 of 1 in force.
Market reach
- European Union
- EUDAMED actor, 1 certificate
- United States
- FDA FEI
- Authorised rep.
- Shanghai International Holding Corp. GmbH(Europe)DE
Catalogue
Search and filter all 23 devicesCompany details
- EUDAMED SRN
- CN-MF-000030072
- FDA FEI number
- 3013039893
- EUDAMED status
- Active
- EUDAMED registered name
- Shanghai Handy Medical Equipment Co., Ltd.
- EUDAMED abbreviated name
- Handy
- Registered address
- Building No.11, Lane 177, Fulian Er Road, 201906, Shanghai, China
- [email protected]
- Phone
- 86-21-56766108
- PRRC contact
- Qiangjiang Chen
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 23 Mar 2030
TÜV SÜD Product Service GmbH 0123 1 certificate
- G10 074840 0015 Active
Quality management system EU MDR
- Issued
- 24 Mar 2025
- Expires
- 23 Mar 2030
Frequently asked questions
How many devices does Shanghai Handy Medical Equipment Co., Ltd. have in the registry?
The registry currently lists 23 devices for Shanghai Handy Medical Equipment Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shanghai Handy Medical Equipment Co., Ltd.'s devices?
Among its 23 most recently registered devices, Shanghai Handy Medical Equipment Co., Ltd. has devices listed in EUDAMED (22 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 Shanghai Handy Medical Equipment Co., Ltd.'s devices fall under?
Among its 23 most recently registered devices, the classes recorded for Shanghai Handy Medical Equipment Co., Ltd.'s devices are Class I, Class IIa, Class IIb and Class II. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Shanghai Handy Medical Equipment Co., Ltd.?
EUDAMED lists 1 certificate for Shanghai Handy Medical Equipment Co., Ltd. (quality management system) under MDR. 1 is recorded with the status issued. The most recent was issued on 24 Mar 2025.
What are the newest devices from Shanghai Handy Medical Equipment Co., Ltd. in the registry?
The most recently registered devices listed for Shanghai Handy Medical Equipment Co., Ltd. include Digital Dental X-ray Imaging System, HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2), Intraoral Camera and Sensor Holder.