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Enova Illumination

by Enova Illumination Inc. 8 variants

Ref 80801-003

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0850025993EnovaDentSysZP Basic UDI-DI 00810186670160UDI-DIDate13 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00810186670160 UDI-DI Date10 Dec 2025ListedStatusListed GUDID: in commercial distribution

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

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  • Withdrawn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

Generic Name
Noninvasive device battery charger
Device Name
Clip-On LED Light System with Battery Accessories
Model / Reference
80801-003
Primary DI / UDI-DI
00810186670160
Basic UDI-DI
0850025993EnovaDentSysZP
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 market of registration
Malta
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000054671
Authorised representative
Advena Limited MT-AR-000000234

Other devices from Enova Illumination, Inc

See all devices from Enova Illumination, Inc →

Properties

  • Premarket Exempt

Other properties (23)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No