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Mini Otoscope, FO, Silver Grey

by D-SAM International

Ref 5203-6Model 5203-1

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 7 Nov 2026. What this means

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8964003650-OTOSCOPES-5T Basic UDI-DI 08964003652654UDI-DIDate24 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Mini Otoscope, FO, Black
Model / Reference
5203-1, 5203-6
Primary DI / UDI-DI
08964003652654
Basic UDI-DI
8964003650-OTOSCOPES-5T
EMDN Code
Z12149006 Direct outpatient otoscopes
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
PK-MF-000030388
Authorised representative
CS Active LV-AR-000011602

Other devices from D-SAM International

See all devices from D-SAM International →

Properties

  • 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