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Rho

by 16 Bit Inc Canada EUDAMED

Ref 06287194090084Model (01)06287194090084 EMDN Z11030592

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number628719409RhoVV Basic UDI-DIDate27 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Model / Reference
(01)06287194090084, 06287194090084
Primary DI / UDI-DI
06287194090084
Basic UDI-DI
628719409RhoVV
Direct Marketing DI
06287194090084
EMDN Code
Z11030592 Radiology instruments - medical device software
Device Class
Class IIa
Special Device Type
Software
Market of Registration
Malta

Manufacturer details

EUDAMED SRN
CA-MF-000048819
Authorised representative
Advena Limited MT-AR-000000234

Other devices from 16 Bit, Inc.

  • Rho

    Class II

  • Rho Radiology Software

    Class II

Properties & raw data

Show properties, registry sources and raw records
Other properties (13)
  • Sterile: 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

Sources (1)

  • EUDAMED b87dc3bc-1b5a-4b50-b132-8db65685ae33 61 fields · synced 23 Oct 2026