Skip to content

Enova Illumination 820004

by Enova Illumination, Inc

Ref 820004-001

Enova Illumination 820004 is a Class I device made by Enova Illumination, Inc, registered in EUDAMED on 10 Jul 2026 (Basic UDI-DI 0850025993EnovaLoupeTG) and listed in FDA GUDID since 27 Jan 2022 (UDI-DI 00850025993432), 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 Number0850025993EnovaLoupeTG Basic UDI-DI 00850025993432UDI-DIDate10 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00850025993432 UDI-DI Date27 Jan 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0850025993EnovaLoupeTG registered 10 Jul 2026 Active
  • FDA GUDID UDI-DI 00850025993432 listed 27 Jan 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00850025993432
  2. Registered EUDAMED 0850025993EnovaLoupeTG

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  • Withdrawn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
Surgical binoculars, reusable
Device name
Surgical Loupes
Model / reference
820004-001 EUDAMED
820004 GUDID
Primary DI / UDI-DI
00850025993432
Basic UDI-DI
0850025993EnovaLoupeTG
FDA product code
FSP
EMDN code
V80 Clinical use accessories not included in other classes
GMDN term
Surgical binoculars, reusable
Device class
Class I
Regulation number
878.4800
EU registration type
Standard device
EU market of registration
Malta
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / referenceEUDAMED
820004-001
GUDID
820004

Related devices

Category: Surgical binoculars, reusable

Other devices from Enova Illumination, Inc

See all devices from Enova Illumination, Inc →

Properties

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