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MEDRAD® Spectris MR Injector

by Bayer Medical Care Inc.

Ref SIT 96V510(k) K935668

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K935668↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0616258TFCN-0002PS Basic UDI-DI 00616258024486UDI-DIDate12 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00616258024486 UDI-DI Date6 May 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK935668 Date25 Sep 1995ClearedStatusActive

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

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k) · GUDID

Trade Name
MEDRAD® Spectris MR Injector EUDAMED
MRI Integral “T” with Check Valve for MEDRAD® Spectris MR Injector GUDID
Generic Name
Angiographic syringe
Model / Ref / Catalog
SIT 96V
Primary DI / UDI-DI
00616258024486
Basic UDI-DI
0616258TFCN-0002PS
510(k) Number
FDA Product Code
LNH
EMDN Code
A03020101 Low pressure extension lines
GMDN Term
Angiographic syringe
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1000
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
FDA applicant
Medrad, Inc.
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

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

Other properties (18)

  • 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