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MEDRAD® Mark 7 Arterion Disposables

by Bayer Medical Care Inc.

Ref ART 700 SYR

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0616258TFCN-0091IIaZ5 Basic UDI-DI 00616258024356UDI-DIDate5 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00616258024356 UDI-DI Date6 May 2024ListedStatusListed GUDID: in commercial distribution

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 · FDA

    • Terminated Z-0745-2019 FDA Class II initiated 14 Dec 2018

    If the head mount knob is not properly tightened and the operator directly uses the injector head to move the unit, it may become disengaged, causing the injector head to become loose or fall.

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  • Withdrawn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
MEDRAD® Mark 7 Arterion Disposables EUDAMED
MEDRAD® Mark 7 Arterion Disposable Syringe 150 mL with Quick Fill Tube GUDID
Generic Name
Angiographic syringe
Model / Ref / Catalog
ART 700 SYR
Primary DI / UDI-DI
00616258024356
Basic UDI-DI
0616258TFCN-0091IIaZ5
510(k) Number
FDA Product Code
DXT
EMDN Code
A02010401 Syringes for contrast media injector, single-use
GMDN Term
Angiographic syringe
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1650
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

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

Related devices

Category: Angiography kit

Other devices from Bayer Medical Care Inc.

See all devices from Bayer Medical Care Inc. →

Properties

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

Other properties (16)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: 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