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Ophthalmoscope Set, PRIMA Basic, 2.5V WOSB

by Medical Devices (Pvt) Ltd EUDAMED

Active European Union

Ref 808-808-26

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number896110278OPHS808TN Basic UDI-DIDate22 Nov 2025RegisteredStatusActive

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  • Withdrawn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

Device Name
Ophthalmoscope
Model / Reference
808-808-26
Primary DI / UDI-DI
08961102783685
Basic UDI-DI
896110278OPHS808TN
EMDN Code
Z12120114 Ophthalmoscopes
Device Class
Class I
Market of Registration
Germany

Manufacturer details

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

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Properties

Show properties
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