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Enova Illumination 80098

by Enova Illumination, Inc

Ref 80098

Enova Illumination 80098 is a Class I device made by Enova Illumination, Inc, registered in EUDAMED on 22 May 2026 (Basic UDI-DI 0850025993EnovaHLSysGQ) and listed in FDA GUDID since 27 Jan 2022 (UDI-DI 00850025993494), active as of 22 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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850025993EnovaHLSysGQ Basic UDI-DI 00850025993494UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850025993494 UDI-DI Date27 Jan 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0850025993EnovaHLSysGQ registered 22 May 2026 Active
  • FDA GUDID UDI-DI 00850025993494 listed 27 Jan 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850025993494
  2. Registered EUDAMED 0850025993EnovaHLSysGQ

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  • Withdrawn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
Enova Illumination
Generic name
Head-worn lamp
Device name
LED Surgical Headlight with Battery Accessories
Model / reference
80098
Primary DI / UDI-DI
00850025993494
Basic UDI-DI
0850025993EnovaHLSysGQ
FDA product code
HPP
EMDN code
Z129004 Light sources
GMDN term
Head-worn lamp
Device class
Class I
Regulation number
886.4335
EU registration type
Standard device
EU market of registration
Malta
GUDID distribution status
In Commercial Distribution

Related devices

Category: Head-worn lamp

Other devices from Enova Illumination, Inc

See all devices from Enova Illumination, Inc →

Properties

  • Premarket exempt
Other properties (24, all answered No)