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Cardiocycle Medical(Suzhou) Co., Ltd.

Active in EUDAMED

Chinafrom SRN EUDAMED FDA SRN CN-MF-000046454

Devices
106
Registrations
EUDAMEDFDA
FDA recalls
0

At a glance

Counted by deviCERTS from registry records

EU certificates

2 of 2 in force.

See certificates

Market reach

European Union
EUDAMED actor, 2 certificates
United States
FDA establishment

What Cardiocycle Medical(Suzhou) Co., Ltd. makes

Cardiocycle Medical(Suzhou) Co., Ltd. manufactures introducer sheath sets, which are used in vascular access procedures to facilitate the insertion of catheters and guidewires into blood vessels.

The company’s introducer sheath sets are classified as Class II devices under FDA regulations and are listed via the 510(k) pathway. The manufacturer is based in the US.

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

Catalogue106

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Rows 1-50 of 106

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Company details

EUDAMED SRN
CN-MF-000046454
DUNS number
725618796
EUDAMED status
Active
EUDAMED registered name
Cardiocycle Medical (Suzhou) Co., Ltd
EUDAMED abbreviated name
Cardiocycle Medical (Suzhou)
Registered address
Unit 401&501, Building C15, 215000, Suzhou,Jiangsu, China
Phone
+86 512-62520838
PRRC contact
Lei Wang(public in EUDAMED)

EUDAMED certificates2

2 certificates2 valid, 0 expiredMDR 2next expiry 27 Apr 2031

EUDAMED certificates (2)

BSI Group The Netherlands B.V. 2797 2 certificates

  • MDR 822136 Active

    Quality management system EU MDR

    Issued
    28 Apr 2026
    Expires
    27 Apr 2031
  • MDR 822137 Active

    Technical documentation EU MDR

    Issued
    28 Apr 2026
    Expires
    27 Apr 2031

FDA establishments1

Registered with the FDA under this company group, matched by name.

  • Cardiocycle Medical(Suzhou) Co., Ltd. Suzhou Jiangsu · CN FEI 3042279517

Frequently asked questions

How many devices does Cardiocycle Medical(Suzhou) Co., Ltd. have in the registry?

The registry currently lists 106 devices for Cardiocycle Medical(Suzhou) Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Cardiocycle Medical(Suzhou) Co., Ltd.'s devices?

Among its 50 most recently registered devices, Cardiocycle Medical(Suzhou) Co., Ltd. has devices listed in EUDAMED (44 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Cardiocycle Medical(Suzhou) Co., Ltd.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Cardiocycle Medical(Suzhou) Co., Ltd.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What EUDAMED certificates are recorded for Cardiocycle Medical(Suzhou) Co., Ltd.?

EUDAMED lists 2 certificates for Cardiocycle Medical(Suzhou) Co., Ltd. (quality management system; technical documentation) under MDR. 2 are recorded with the status issued. The most recent was issued on 28 Apr 2026.

What are the newest devices from Cardiocycle Medical(Suzhou) Co., Ltd. in the registry?

The most recently registered devices listed for Cardiocycle Medical(Suzhou) Co., Ltd. include CorPassTM Introducer Sheath Set CPSH1245, CorPassTM Introducer Sheath Set CPSH1345, CorPassTM Introducer Sheath Set CPSH1265 and CorPassTM Introducer Sheath Set CPSH1333.

Which FDA establishments are linked to Cardiocycle Medical(Suzhou) Co., Ltd.?

1 FDA establishment is linked to Cardiocycle Medical(Suzhou) Co., Ltd. in the registry; they are listed on the company page.

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