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8Ch Medial Coil Sen 1.5T

by Dunlee 2 variants

Ref 300006544371

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

CE MDR

Valid until

1 Apr 2027

CE MDR certificate

FDA recalls

None found

in data synced 25 Oct 2026

Documents

1 certificate

Certifier DEKRA Certification B.V.

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 Number0884838BM909TR Basic UDI-DI 00884838109544UDI-DIDate8 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00884838109544 UDI-DI Date1 Apr 2022ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 2243595CE03 Expiring Amended Expires in 152 days

    Quality management system EU MDR

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

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

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  • Withdrawn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
8Ch Medial Coil Sen 1.5T EUDAMED
Dunlee Sentinelle GUDID
Generic Name
MRI system coil, radio-frequency
Device Name
Siemens Breast Coil PMS
Model / Ref / Catalog
300006544371, 8Ch Medial Coil Sen 1.5T
Primary DI / UDI-DI
00884838109544
Basic UDI-DI
0884838BM909TR
Direct Marketing DI
00884838109544
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
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
300006544371
GUDID
8Ch Medial 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