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Apollo Standard Universal EENT Diagnostic Set with Rechargeable Battery and Charging Station in Carrying Case

by Surtex Instruments Ltd

Ref DI-740-01, DI-740-00Model 50554459DIAGNOSTI149006J2

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50554459DIAGNOSTUV Basic UDI-DI Date15 Mar 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  • Withdrawn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

Trade Name
Apollo Standard Universal EENT Diagnostic Set with Rechargeable Battery and Charging Station in Carrying Case
Apollo Standard Universal EENT Diagnostic Set
Device Name
Diagnostic Instruments
Direct outpatient otoscopes
Model / Reference
DI-740-01, DI-740-00, 50554459DIAGNOSTI149006J2
Primary DI / UDI-DI
05056111373002, 05055445928742
Basic UDI-DI
50554459DIAGNOSTUV, 50554459DIAGNOSTI149006J2
EMDN Code
Z12149006 Direct outpatient otoscopes
Device Class
Class I
EU 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

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Properties

  • 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