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rTOP 1

by Roclub GmbH

Ref rTOP

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number912013887rTOPMG Basic UDI-DI 09120138870014UDI-DIDate17 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09120138870014 UDI-DI Date26 Mar 2025ListedStatusListed GUDID: not 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 25 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  • Withdrawn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

Trade Name
rTOP
Generic Name
Radiology DICOM image processing application software
Model / Ref / Catalog
rTOP EUDAMED
1 GUDID
Primary DI / UDI-DI
09120138870014
Basic UDI-DI
912013887rTOPMG
Direct Marketing DI
09120138870014
510(k) Number
FDA Product Code
LLZ
EMDN Code
Z1105018099 Magnetic resonance (MR) systems - hardware accessories - other
GMDN Term
Radiology DICOM image processing application software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.2050
EU market of registration
Germany
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
rTOP
GUDID
1
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from Roclub GmbH

  • rTOP

    Class II

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Expiration Date: No