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Optomic OPTIMUS ELITE WORKSTATION

by Optomic España SA

Ref 67633056

Optomic OPTIMUS ELITE WORKSTATION is an ENT examination/treatment system (EU MDR Class IIa; FDA Class I; FDA product code ETF, Unit, Examining/Treatment, Ent) made by Optomic España SA, registered in EUDAMED on 21 May 2026 (Basic UDI-DI 84360415814353F) and listed in FDA GUDID since 18 Jul 2024 (UDI-DI 08436041581178), active as of 23 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number84360415814353F Basic UDI-DI 08436041581178UDI-DIDate21 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08436041581178 UDI-DI Date18 Jul 2024ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 84360415814353F registered 21 May 2026 Active
  • FDA GUDID UDI-DI 08436041581178 listed 18 Jul 2024 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08436041581178
  2. Registered EUDAMED 84360415814353F

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Optimus Elite EUDAMED
Optomic GUDID
Generic name
ENT examination/treatment system
Device name
Workstation type C
Model / reference
67633056 EUDAMED
OPTIMUS ELITE WORKSTATION GUDID
Primary DI / UDI-DI
08436041581178
Basic UDI-DI
84360415814353F
FDA product code
ETF
EMDN code
Z121402 ENT treatment units
GMDN term
ENT examination/treatment system
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
874.5300
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
67633056
GUDID
OPTIMUS ELITE WORKSTATION
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: ENT examination/treatment system

Similar devices in this category

Other devices filed under ENT INSTRUMENTS.

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Properties

  • Premarket exempt
  • Serial number
Other properties (23, all answered No)