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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

At a glance

Counted by deviCERTS from registry records

EU certificates

4 of 5 in force.

See certificates

Market reach

European Union
EUDAMED actor, 5 certificates

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

Newest first, rows 1-50 of 111

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  • Captor Ref HC*TDE-5030

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-3-10-HX-ES

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-5-10-3D-SS

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-4-12-HX-SS

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-6-20-3D-SS

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-10-20-3D-STD

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-6-10-3D-STD

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-6-20-HX-SS

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-4-6-HX-SS

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-1.5-2-HX-ES

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-10-30-3D-STD

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-16-50-3D-STD

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-25-50-3D-STD

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-16-40-3D-STD

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-9-20-3D-STD

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-6-10-3D-SS

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-2.5-6-HX-ES

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-7-30-3D-STD

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-6-15-3D-SS

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-3.5-8-3D-ES

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-1.5-3-HX-ES

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-2-2-HX-ES

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-2-6-HX-ES

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-4-10-3D-SS

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-3-8-HX-ES

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-3-4-3D-ES

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-14-50-3D-STD

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-4-15-3D-STD

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-2.5-3-HX-ES

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-12-40-3D-STD

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-1-4-3D-ES

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-12-50-3D-STD

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-3-8-3D-ES

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-18-50-3D-STD

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-1.5-2-3D-ES

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-8-15-3D-STD

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-1.5-3-3D-ES

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-4-8-3D-SS

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-4-10-3D-STD

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-1.5-4-3D-ES

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-10-40-3D-STD

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-2-3-3D-ES

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-3.5-6-3D-STD

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-3-6-3D-ES

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-5-20-HX-SS

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-1.5-1-HX-ES

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-4-12-3D-SS

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-2.5-4-HX-ES

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-7-20-3D-STD

    Active Regimes: CE MDR Registry: EUDAMED Class:III

  • Sealsac Ref ECS-8-20-3D-STD

    Active Regimes: CE MDR Registry: EUDAMED Class:III

Rows 1-50 of 111

Showing 1-50 of 111

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

Frequently asked questions

How many devices does Shanghai Heartcare Medical Technology Co., Ltd. have in the registry?

The registry currently lists 111 devices for Shanghai Heartcare Medical Technology Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Shanghai Heartcare Medical Technology Co., Ltd.'s devices?

Among its 50 most recently registered devices, Shanghai Heartcare Medical Technology Co., Ltd. has devices listed in EUDAMED (50 devices).

What risk classes do Shanghai Heartcare Medical Technology Co., Ltd.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Shanghai Heartcare Medical Technology Co., Ltd.'s devices are Class III. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Shanghai Heartcare Medical Technology Co., Ltd.?

EUDAMED lists 5 certificates for Shanghai Heartcare Medical Technology Co., Ltd. (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 Co., Ltd. in the registry?

The most recently registered devices listed for Shanghai Heartcare Medical Technology Co., Ltd. include CAPTOR and SEALSAC.

Generated automatically from registry data and not verified by a human reviewer.