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dS Breast 16Ch 1.5T

by Philips Medical Systems Nederland B.V.

Ref 459801729882

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

CE MDR

Valid until

1 Apr 2027

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DEKRA Certification B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number2243595CE02 Date24 Sep 2026IssuedStatusExpiring expires 1 Apr 2027
United StatesGUDID listing GUDID Number00884838118393 UDI-DI Date15 Aug 2023ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2243595CE02 Expiring Amended Expires in 151 days

    Quality management system EU MDR

    Certifier
    DEKRA Certification B.V. 0344
    Issued
    24 Sep 2026
    Expires
    1 Apr 2027
    Reason
    Other

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  • Withdrawn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
dS Breast 16Ch 1.5T EUDAMED
MR Coils GUDID
Generic Name
MRI system coil, radio-frequency
Device Name
Philips Breast Coil PMS
Model / Ref / Catalog
459801729882, dS Breast 16Ch 1.5T
Primary DI / UDI-DI
00884838118393
Basic UDI-DI
0884838BM914TJ
FDA Product Code
MOS
EMDN Code
Z1105018001, Z1105018002, Z1105018099
GMDN Term
MRI system coil, radio-frequency
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 · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
459801729882
GUDID
dS Breast 16Ch 1.5T
Device ClassEUDAMED
Class IIa
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