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Fortress Introducer Sheath System

by Contract Medical International GmbH 14 variants

Ref 358813

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

CE MDR

Valid until

1 Jun 2027

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number4251244500000113F Basic UDI-DI 04251244503628UDI-DIDate23 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04251244503628 UDI-DI Date24 Jun 2024ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2254506CE03 Expiring Expires in 212 days

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    6 Jun 2024
    Expires
    1 Jun 2027

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade Name
Fortress Introducer Sheath System EUDAMED
Biotronik Fortress Introducer Sheath System GUDID
Generic Name
Vascular catheter introduction set, nonimplantable
Model / Ref / Catalog
358813, 4F, 45 cm, crossover
Primary DI / UDI-DI
04251244503628
Basic UDI-DI
4251244500000113F
FDA Product Code
DYB, DRE
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
GMDN Term
Vascular catheter introduction set, nonimplantable
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1340, 870.1310
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Length — 45 Centimeter
Lumen/Inner Diameter — 1.62 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
358813
GUDID
4F; 45 cm; crossover
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000007409

Related devices

Category: Vascular catheter introduction set, nonimplantable

Other devices from Contract Medical International GmbH

See all devices from Contract Medical International GmbH →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (17)

  • 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
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No