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Me-Check

by Espansione Marketing SpA

Ref ME-CHECK

Me-Check is a multi-purpose digital medical camera lens (EU MDD Class IIa; FDA Class II; FDA product code PJZ, Camera, Ophthalmic, General-Use) made by Espansione Marketing SpA, registered in EUDAMED on 1 Jun 2026 (Basic UDI-DI 80563897MECHECKMGD00R3) and listed in FDA GUDID since 6 Jun 2018 (UDI-DI 08056389700002), active as of 25 Oct 2026.

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

CE MDR CE MDD

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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number80563897MECHECKMGD00R3 Basic UDI-DI 08056389700002UDI-DIDate1 Jun 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number80563897MECHECKMGD00R3 Basic UDI-DI 08056389700002UDI-DIDate1 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08056389700002 UDI-DI Date6 Jun 2018ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 80563897MECHECKMGD00R3 registered 1 Jun 2026 Active· +1 more in the status table
  • FDA GUDID UDI-DI 08056389700002 listed 6 Jun 2018 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08056389700002
  2. Registered EUDAMED 80563897MECHECKMGD00R3

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Multi-purpose digital medical camera lens, extraocular
Device name
Ophtalmology assessments and diagnosis instruments
Device for acquiring and displaying images of the eye and parts thereof
Model / Ref / Catalog
ME-CHECK
Primary DI / UDI-DI
08056389700002
Basic UDI-DI
80563897MECHECKMGD00R3, B-08056389700002
FDA product code
PJZ
EMDN code
Z12120299, Z12120199
GMDN term
Multi-purpose digital medical camera lens, extraocular
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
886.1120
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

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

Related devices

Category: Multi-purpose digital medical camera lens, extraocular

Similar devices

Also classified as Multi-purpose digital medical camera lens, extraocular.

Similar devices in this category

Other devices filed under OPHTALMOLOGY ASSESSMENTS AND DIAGNOSIS INSTRUMENTS – OTHER.

Other devices from Espansione Marketing SpA

See all devices from Espansione Marketing SpA →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)