Suzhou Microport Orthorecon Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED FDA SRN CN-MF-000001566 FEI 3014662844
- Devices
- 226
- 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
What Suzhou Microport Orthorecon Co., Ltd. makes
Suzhou Microport Orthorecon Co., Ltd. manufactures the MedalOne Total Knee System, a prosthetic device designed for total knee arthroplasty to replace damaged knee joints.
The MedalOne Total Knee System is classified as a Class II medical device in the US and is listed under the FDA’s 510(k) pathway. The company is based in the United States.
Catalogue
Search and filter all 226 devicesShowing 1-50 of 226
Company details
- EUDAMED SRN
- CN-MF-000001566
- FDA FEI number
- 3014662844
- EU VAT number
- NA
- EUDAMED status
- Active
- EUDAMED registered name
- Suzhou MicroPort OrthoRecon Co., Ltd
- EUDAMED abbreviated name
- Suzhou MicroPort OrthoRecon Co., Ltd.
- Registered address
- No. 151, Building 2 and 3,Fengli Street, 215000, Suzhou, Jiangsu, China
- [email protected]
- PRRC contact
- Yujian Mao
EUDAMED certificates
1 certificate1 valid, 0 expiredMDR 1next expiry 19 Feb 2031
TÜV SÜD Product Service GmbH 0123 1 certificate
- G70 097657 0006 Active
Technical documentation EU MDR
- Issued
- 20 Feb 2026
- Expires
- 19 Feb 2031
Frequently asked questions
How many devices does Suzhou Microport Orthorecon Co., Ltd. have in the registry?
The registry currently lists 226 devices for Suzhou Microport Orthorecon Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Suzhou Microport Orthorecon Co., Ltd.'s devices?
Among its 50 most recently registered devices, Suzhou Microport Orthorecon Co., Ltd. has devices listed in EUDAMED (50 devices).
What risk classes do Suzhou Microport Orthorecon Co., Ltd.'s devices fall under?
Among its 50 most recently registered devices, the classes recorded for Suzhou Microport Orthorecon Co., Ltd.'s devices are Class III. Each device page shows its own class and authorisation.
What EUDAMED certificates are recorded for Suzhou Microport Orthorecon Co., Ltd.?
EUDAMED lists 1 certificate for Suzhou Microport Orthorecon Co., Ltd. (technical documentation) under MDR. 1 is recorded with the status issued. The most recent was issued on 2026-02-20.
What are the newest devices from Suzhou Microport Orthorecon Co., Ltd. in the registry?
The most recently registered devices listed for Suzhou Microport Orthorecon Co., Ltd. include EVOLUTION MPX™ TIBIAL INSERT, SOSUPERIOR™ PATELLA, EVOLUTION MPX™ TIBIAL BASE and EVOLUTION MPX™ FEMORAL COMPONENT.