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Diagnostic Handle, VISIO 2000, Plug-in 3.5V with Red Push Button

by Medical Devices (Pvt) Ltd Pakistan EUDAMED

Ref 808-039-35

EMDN Z12021007,Z12120114

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number896110278OTOVIS8086A Basic UDI-DIDate27 Nov 2025RegisteredStatusActive

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
Otoscope
Model / Reference
808-039-35
Primary DI / UDI-DI
08964000576267
Basic UDI-DI
896110278OTOVIS8086A
EMDN Code
Z12021007,Z12120114
Device Class
Class I
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
PK-MF-000021845
Authorised representative
Obelis s.a. BE-AR-000000106

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 4182e4a8-0205-4e16-9b3b-51af3b0c443d 61 fields · synced 22 Oct 2026