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Biotronik Fortress Introducer Sheath System 6F; 45 cm; straight

by Contract Medical International GmbH

Ref 386594

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

CE MDR

Valid until

1 Jun 2027

CE MDR certificate

FDA recalls

1 ongoing

This device is named in the recall

Documents

1 certificate

Certifier DEKRA Certification 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
European UnionCE/MDR EUDAMED Number4251244500000113F Basic UDI-DI 04251244503703UDI-DIDate23 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04251244503703 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

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-2532-2025 FDA Class II initiated 30 Jul 2025

    Units may have been packaged with an incorrect pouch label, which lists the reference number and unique device identifier of the 4F version of the device, rather than the packaged 6F version.

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  • Withdrawn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
386594, 6F, 45 cm, straight
Primary DI / UDI-DI
04251244503703
Basic UDI-DI
4251244500000113F
510(k) Number
FDA Product Code
DYB, DRE
EMDN Code
C0502 Cardiovascular introducer sheaths, valved
GMDN Term
Vascular catheter introduction set, nonimplantable
Models / Variants
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 — 2.20 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
386594
GUDID
6F; 45 cm; straight
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Cleared under the same submission (K153197)

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