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Suzhou Microport Orthorecon Co., Ltd.

Active in EUDAMED

Chinafrom SRN EUDAMED FDA SRN CN-MF-000001566 FEI 3014662844

Devices
226
Registrations
EUDAMEDFDA
FDA recalls
0

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.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

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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
PRRC contact
Yujian Mao(public in EUDAMED)

EUDAMED certificates1

1 certificate1 valid, 0 expiredMDR 1next expiry 19 Feb 2031

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G70 097657 0006 Active

    Technical documentation EU MDR

    Issued
    20 Feb 2026
    Expires
    19 Feb 2031