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OR Head Holder LUCY with HeadCoilSet Siemens 1.5T

by NORAS MRI products GmbH

Ref 119734510(k) K211658

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) K211658↗

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 Number42512692LUCYNL Basic UDI-DI 04251269204050UDI-DIDate30 Jul 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04251269204050 UDI-DI Date18 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK211658 Date3 Mar 2022ClearedStatusActive

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  • Withdrawn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

Generic Name
MRI system coil, radio-frequency
Device Name
OR Head Holder LUCY with HeadCoilSet Philips/Siemens 1.5T/3T
Model / Ref / Catalog
119734, 01
Primary DI / UDI-DI
04251269204050
Basic UDI-DI
42512692LUCYNL
Direct Marketing DI
04251269204050
510(k) Number
FDA Product Code
MOS, HBL
EMDN Code
Z11059080 Various magnetic resonance imaging instruments - hardware accessories
GMDN Term
MRI system coil, radio-frequency
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.1000, 882.4460
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
119734
GUDID
01
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
DE-MF-000006182

Other devices from Moras Mri Products GmbH

See all devices from Moras Mri Products GmbH →

Properties

  • Reusable
  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: 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