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CorPassTM Introducer Sheath Set

by Cardiocycle Medical (Suzhou) Co., Ltd

Ref CPSH1233

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06974949030500 UDI-DIDate11 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 AmericaFrance
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

EU market availability

Made available in 1 country, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • France since 19 Jun 2026

Last checked 23 Oct 2026.

Specification

EUDAMED · GUDID

Generic Name
Vascular catheter introduction set, nonimplantable
Model / Reference
CPSH1233
Primary DI / UDI-DI
06974949030500
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
France
GUDID distribution status
In Commercial Distribution
Size
Introducer Sheath Compatibility — 12 French
Length — 33 Centimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

EUDAMED SRN
CN-MF-000046454
Authorised representative
Cardiocycle R&D Limited IE-AR-000045257

Properties

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

Other properties (19)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No