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Encompass 15 Channel MRI Head Coil - 3T

by NORAS MRI products GmbH

Ref 119781

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

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 Number42512692ENCOMPASS30L8 Basic UDI-DI 04251269204470UDI-DIDate19 Mar 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number04251269204470 UDI-DI Date15 Nov 2019ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Generic Name
MRI system coil, radio-frequency
Model / Ref / Catalog
119781, 01
Primary DI / UDI-DI
04251269204470
Basic UDI-DI
42512692ENCOMPASS30L8
Direct Marketing DI
04251269204470
510(k) Number
FDA Product Code
MOS, HBL
EMDN Code
Z11059099 Various magnetic resonance imaging instruments – other
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
MRI Safety
MR Safe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
119781
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

  • Prescription Use
  • Manufacturing Date

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
  • Serial Number: No
  • Expiration Date: No