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Apollo PLUS Fiber Optic Universal EENT Diagnostic Set Complete Including 1 x Otoscope Head, 1 x Ophthalmoscope Head, 1 x Battery Handle, 1 x Nasal Illuminator, 1 x Straight Illuminator, 1 x Plain Mirror 20 mm, 1 x Tongue Depressor, 1 x 1Reusable Ear Specu

by Surtex Instruments Ltd United Kingdom EUDAMED

Ref DI-760-00Model 50554459DIAGNOSTI149006J2 EMDN Z12149006

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50554459DIAGNOSTUV Basic UDI-DIDate15 Mar 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  • Withdrawn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

Trade Name
Apollo PLUS Fiber Optic Universal EENT Diagnostic Set Complete Including 1 x Otoscope Head, 1 x Ophthalmoscope Head, 1 x Battery Handle, 1 x Nasal Illuminator, 1 x Straight Illuminator, 1 x Plain Mirror 20 mm, 1 x Tongue Depressor, 1 x 1Reusable Ear Specu
Apollo PLUS Fiber Optic Universal EENT Diagnostic Set Complete Including 1 x Otoscope Head, 1 x Ophthalmoscope Head, 1 x Battery Handle, 1 x Nasal Illuminator, 1 x Straight Illuminator, 1 x Plain Mirror 20 mm, 1 x Tongue Depressor
Device Name
Diagnostic Instruments
Direct outpatient otoscopes
Model / Reference
DI-760-00, 50554459DIAGNOSTI149006J2
Primary DI / UDI-DI
05056111340141
Basic UDI-DI
50554459DIAGNOSTUV, 50554459DIAGNOSTI149006J2
EMDN Code
Z12149006 Direct outpatient otoscopes
Device Class
Class I
Market of Registration
Spain

Manufacturer details

EUDAMED SRN
GB-MF-000023183
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Surtex Instruments Ltd

See all devices from Surtex Instruments Ltd →

Properties & raw data

Show properties, registry sources and raw records
  • Reusable YesEUDAMEDNoEUDAMED
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 (2)

  • EUDAMED 79a7182e-1596-4d49-b6f2-d4e3e02d9e7a 61 fields · synced 25 Oct 2026
  • EUDAMED 05056111340141|50554459DIAGNOSTI149006J2 61 fields · synced 25 Oct 2026