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Otoscope Set, PRIMA Classic, 2.5V WSB, Rechargeable Battery (Included), Hard Case

by Medical Devices (Pvt) Ltd Pakistan EUDAMED

Ref 808-806-27

EMDN Z12021007

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number896110278OTOS808XP Basic UDI-DIDate28 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
808-806-27
Primary DI / UDI-DI
08961102783616
Basic UDI-DI
896110278OTOS808XP
EMDN Code
Z12021007 Middle ear otoscopes
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 53c7442c-a1c0-4633-9592-d58b98a2d05a 61 fields · synced 22 Oct 2026