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Enova Illumination 80100-001

by Enova Illumination, Inc

Ref 80100-001

Enova Illumination 80100-001 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 00850025993647), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850025993EnovaHLSysGQ Basic UDI-DI 00850025993647UDI-DIDate22 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850025993647 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 00850025993647 listed 27 Jan 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850025993647
  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  • Withdrawn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
Noninvasive device battery charger
Device name
LED Surgical Headlight with Battery Accessories
Model / reference
80100-001
Primary DI / UDI-DI
00850025993647
Basic UDI-DI
0850025993EnovaHLSysGQ
FDA product code
HPP
EMDN code
V80 Clinical use accessories not included in other classes
GMDN term
Noninvasive device battery charger
Device class
Class I
Regulation number
886.4335
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Related devices

Category: Noninvasive device battery charger

Similar devices in this category

Other devices filed under CLINICAL USE ACCESSORIES NOT INCLUDED IN OTHER CLASSES.

Other devices from Enova Illumination, Inc

See all devices from Enova Illumination, Inc →

Properties

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