Skip to content

Colpoitpro

by AmbalSoft InfoTech Private Limited India EUDAMED

Ref ASITKTB2HDEX3Model COLPOITPRO COLPOSCOPY IMAGING SOFTWARE

EMDN Z12020492

Regulatory status

as of 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8908020602COV24D54 Basic UDI-DIDate29 Apr 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Colpoitpro Colposcopy Imaging Software
Model / Reference
COLPOITPRO COLPOSCOPY IMAGING SOFTWARE, ASITKTB2HDEX3
Primary DI / UDI-DI
08908020602179
Basic UDI-DI
8908020602COV24D54
Direct Marketing DI
08908020602179
EMDN Code
Z12020492 Instruments for the acquisition and management of endoscopic and minimally invasive surgery images - medical device software
Device Class
Class I
Special Device Type
Software
Market of Registration
Romania

Manufacturer details

EUDAMED SRN
IN-MF-000029308
Authorised representative
Amstermed B.V. NL-AR-000001971

Other devices from AmbalSoft InfoTech Private Limited

See all devices from AmbalSoft InfoTech Private Limited →

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 9531510a-029b-40ed-9ebb-9cad7ad45aa5 61 fields · synced 22 Oct 2026