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CorPassTM Introducer Sheath Set CPSH2445

by Cardiocycle Medical(Suzhou) Co., Ltd.

Ref CPSH2445

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

27 Apr 2031

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06974949030876 UDI-DIDate28 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number697494903SH22RL Basic UDI-DIDate9 May 2026RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 822137 Active

    Technical documentation EU MDR

    Notified body
    BSI Group The Netherlands B.V. 2797
    Issued
    28 Apr 2026
    Expires
    27 Apr 2031

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
CorPassTM Introducer Sheath Set
Generic Name
Vascular catheter introduction set, nonimplantable
Model / Reference
CPSH2445
Primary DI / UDI-DI
06974949030876
Basic UDI-DI
697494903SH22RL
510(k) Number
FDA Product Code
DYB
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
870.1340
Market of Registration
Ireland
GUDID distribution status
In Commercial Distribution
Size
Introducer Sheath Compatibility — 24 French
Length — 45 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Related devices

Cleared under the same submission (K254248)

Show all (12)

Other devices from Cardiocycle Medical(Suzhou) Co., Ltd.

See all devices from Cardiocycle Medical(Suzhou) Co., Ltd. →

Properties

  • Sterile
  • Single Use
  • Lot / Batch Number
  • Expiration Date

Other properties (20)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No