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RemotEye Viewer / RemotEye Lite

by NeoLogica s.r.l.

Ref REVModel RemotEye Viewer / RemotEye Lite

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 23 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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++B383RESUITE78 Basic UDI-DI B383REV100300000UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberB383REV100300000 UDI-DI Date8 May 2026ListedStatusListed 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 23 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  • Withdrawn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
RemotEye Viewer
Generic Name
Radiological PACS-dedicated management software
Device Name
RemotEye Viewer / RemotEye Lite
Model / Reference
RemotEye Viewer / RemotEye Lite EUDAMED
REV EUDAMED
10.3.0 GUDID
Primary DI / UDI-DI
B383REV100300000
Basic UDI-DI
++B383RESUITE78
510(k) Number
FDA Product Code
LLZ
EMDN Code
Z11069092 Various digital bioimaging management instruments - medical device software
GMDN Term
Radiological PACS-dedicated management software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.2050
Special Device Type
Software
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
RemotEye Viewer / RemotEye Lite
REV
GUDID
10.3.0
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
IT-MF-000019775

Other devices from Neologica S.R.L.

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number

Other properties (21)

  • 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
  • Manufacturing Date: No