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Dermatoscope

by SG Manufacturers Pakistan EUDAMED

Ref FMO-001-1700-2090 EMDN Z12040108

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8964003248DM045R Basic UDI-DIDate14 May 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  • Withdrawn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 25 Oct 2026

Model / Reference
FMO-001-1700-2090
Primary DI / UDI-DI
08964004012648
Basic UDI-DI
8964003248DM045R
EMDN Code
Z12040108 Dermatoscopes
Device Class
Class I
Market of Registration
Poland

Manufacturer details

EUDAMED SRN
PK-MF-000007106
Authorised representative
International Business Compendious of Sweden SE-AR-000001625

Other devices from SG Manufacturers

See all devices from SG Manufacturers →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable
Other properties (12)
  • Sterile: No
  • Implantable: 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 60a59883-d387-49d3-8a6d-dc5d95720f14 61 fields · synced 25 Oct 2026