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Vanguard Breast MRI Tabletop Coil

by Philips Medical Systems Nederland B.V. 2 variants

Ref 300009396771

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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K926275↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884838BM983U5 Basic UDI-DI 00884838115194UDI-DIDate30 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838115194 UDI-DI Date9 Jun 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK926275 Date28 Oct 1993IssuedStatusActive

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 24 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  • Withdrawn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
Vanguard Breast MRI Tabletop Coil EUDAMED
Dunlee Sentinelle GUDID
Generic Name
MRI system coil, radio-frequency
Device Name
GE Breast Class 1 PMS
Model / Ref / Catalog
300009396771, Vanguard Breast MRI Tabletop Coil
Primary DI / UDI-DI
00884838115194
Basic UDI-DI
0884838BM983U5
Direct Marketing DI
00884838115194
FDA Product Code
MOS
EMDN Code
Z1105018001, Z1105018002, Z1105018099
GMDN Term
MRI system coil, radio-frequency
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
892.1000
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
300009396771
GUDID
Vanguard Breast MRI Tabletop Coil
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000001489

Other devices from Philips Medical Systems Nederland B.V.

See all devices from Philips Medical Systems Nederland B.V. →

Properties

  • Prescription Use
  • Serial Number

Other properties (22)

  • 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
  • Lot / Batch Number: No
  • Expiration Date: No
  • Manufacturing Date: No