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MEDRAD® Stellant CT Injection System with Certegra Workstation

by Bayer Medical Care Inc. EUDAMEDGUDID

Active European Union Open recall

Ref SSH 100F

Regulatory status

as of 28 Oct 2026

Recall ongoing. 1 ongoing FDA recall names this device. See recalls

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0616258TFCN-0082I3T Basic UDI-DIDate5 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00616258027401 UDI-DIDate22 Apr 2022ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-3147-2026 FDA Class II initiated 31 Jul 2026

    Some devices may not have been properly sterilized due to a manufacturing sterilization issue.

Specification

EUDAMED · GUDID

Trade Name
MEDRAD® Stellant CT Injection System with Certegra Workstation EUDAMED
MEDRAD® Stellant Heat Maintainer GUDID
Generic Name
CT contrast medium injection system, line-powered, mobile
Model / Ref / Catalog
SSH 100F
Primary DI / UDI-DI
00616258027401, 00616258026473
Basic UDI-DI
0616258TFCN-0082I3T
510(k) Number
FDA Product Code
DXT
EMDN Code
A030105 Fluids heating systems
GMDN Term
CT contrast medium injection system, line-powered, mobile
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
870.1650
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
US-MF-000007050
Authorised representative
Bayer Medical Care B.V. NL-AR-000000240

Other devices from Bayer Medical Care Inc.

See all devices from Bayer Medical Care Inc. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • 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
  • Expiration Date: No