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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

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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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.

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.

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.