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4Ch Right Lateral Coil Sen 1.5T

by Dunlee EUDAMEDGUDID 2 variants

Expiring European Union

Ref 300006545551

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0884838BM909TR Basic UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838109636 UDI-DIDate1 Apr 2022ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2243595CE03 Expiring Amended Expires in 154 days

    Quality management system EU MDR

    Notified body
    DEKRA Certification B.V. 0344
    Issued
    9 Aug 2026
    Expires
    1 Apr 2027
    Reason
    Mnf data change

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
4Ch Right Lateral Coil Sen 1.5T EUDAMED
Dunlee Sentinelle GUDID
Generic Name
MRI system coil, radio-frequency
Device Name
Siemens Breast Coil PMS
Model / Ref / Catalog
300006545551, 4Ch Right Lateral Coil Sen 1.5T
Primary DI / UDI-DI
00884838109636
Basic UDI-DI
0884838BM909TR
Direct Marketing DI
00884838109636
510(k) Number
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
Market of Registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
300006545551
GUDID
4Ch Right Lateral Coil Sen 1.5T
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
NL-MF-000051589

Other devices from Dunlee

See all devices from Dunlee →

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