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Shanghai Heartcare Medical Technology Co., Ltd.

Active in EUDAMED

Registered as Shanghai HeartCare Medical Technology Corporation Limited in EUDAMED

Chinafrom SRN EUDAMED SRN CN-MF-000001941

Devices
111
Registrations
EUDAMED

What Shanghai Heartcare Medical Technology Co., Ltd. makes

Shanghai Heartcare Medical Technology Co., Ltd. manufactures vascular catheters, including micro catheters, balloon guiding catheters, and distal access catheters designed for interventional cardiology procedures.

These devices are classified as Class II under FDA regulations and are listed via the 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.

Catalogue111

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  • Captor Ref HC*TDE-3015

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Captor Ref HC*TDE-6040

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Captor Ref HC*TDE-3020

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Captor Ref HC*TDE-5040

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Captor ® Ref HC*TDE-6020

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Micro Catheter Ref K202926

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Balloon Guiding Catheter Ref K202916

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Distal Access Catheter Ref K233205

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Captor ® Ref HC*TDE-6030

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Captor ® Ref HC*TDE-4040

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Captor ® Ref HC*TDE-4020

    Active Regimes: CE MDR Registry: EUDAMED Class:III

Rows 101-111 of 111

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Company details

EUDAMED SRN
CN-MF-000001941
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
Phone
+8618621683501
PRRC contact
Guohui Wang(public in EUDAMED)

EUDAMED certificates5

5 certificates4 valid, 0 expired, 1 withdrawn or suspendedMDR 5next expiry 13 Nov 2028

EUDAMED certificates (5)

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 Supplemented

    Quality management system EU MDR

    Issued
    30 Sep 2026
    Expires
    27 Aug 2031
    Reason
    Add device or group
  • MDR.2292-2026/0065 Active Amended

    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