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Ic Profiler 1122800Z

by Sun Nuclear Corporation

Ref 1122

Ic Profiler 1122800Z (1122000-0Z) is a device classified as Class IIb in the EU and Class I in the US made by Sun Nuclear Corporation, registered in EUDAMED on 13 Jun 2025 (Basic UDI-DI 506060888DAICPROFILERMD) with CE/MDR certificate 28620200479 valid until 6 Jan 2028 and listed in FDA GUDID since 23 Jul 2020 (UDI-DI 05060608880751), active as of 23 Oct 2026.

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

CE MDR

Valid until

6 Jan 2028

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier Intertek Medical Notified Body AB

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number506060888DAICPROFILERMD Basic UDI-DI 05060608880751UDI-DIDate13 Jun 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05060608880751 UDI-DI Date23 Jul 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 506060888DAICPROFILERMD registered 13 Jun 2025 Active· +1 more in the status table
  • FDA GUDID UDI-DI 05060608880751 listed 23 Jul 2020 Listed

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Timeline

4 dated events

  1. Listed FDA GUDID 05060608880751
  2. Certificate issued EUDAMED 28620200479
  3. Registered EUDAMED 506060888DAICPROFILERMD
  4. Certificate expires EUDAMED 28620200479

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  • Withdrawn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

Trade name
Ic Profiler
Generic name
Accelerator system quality assurance device
Model / Ref / Catalog
1122 EUDAMED
1122800Z GUDID
1122000-0Z GUDID
Primary DI / UDI-DI
05060608880751
Basic UDI-DI
506060888DAICPROFILERMD
FDA product code
LHO
EMDN code
Z11010180 Linear accelerators - hardware accessories
GMDN term
Accelerator system quality assurance device
Device class
Class IIb EUDAMED
Class I GUDID
Regulation number
892.1940
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
1122
GUDID
1122800Z
Device classEUDAMED
Class IIb
GUDID
Class I

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Accelerator system quality assurance device

Similar devices in this category

Other devices filed under LINEAR ACCELERATORS - HARDWARE ACCESSORIES.

Other devices from Sun Nuclear Corporation

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Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)