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Sl 500

by Essilor International

Ref SL500

Sl 500 (SL500) is an ophthalmic examination slit lamp (EU MDR Class I; FDA Class II; FDA product code HJO, Biomicroscope, Slit-Lamp, Ac-Powered) made by Essilor International, registered in EUDAMED on 17 Feb 2026 (Basic UDI-DI 361502000000ISLITLAMP00L5) and listed in FDA GUDID since 23 Sep 2016 (UDI-DI 03615020000359), 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 Number361502000000ISLITLAMP00L5 Basic UDI-DI 03615020000359UDI-DIDate17 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03615020000359 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 361502000000ISLITLAMP00L5 registered 17 Feb 2026 Active
  • FDA GUDID UDI-DI 03615020000359 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 03615020000359
  2. Registered EUDAMED 361502000000ISLITLAMP00L5

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  • Withdrawn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
Sl 500 EUDAMED
Essilor SL500L GUDID
Generic name
Ophthalmic examination slit lamp
Device name
Slit Lamp
Model / reference
SL500 EUDAMED
SL500L GUDID
Primary DI / UDI-DI
03615020000359
Basic UDI-DI
361502000000ISLITLAMP00L5
FDA product code
HJO
EMDN code
Z12120108 Slit lamps
GMDN term
Ophthalmic examination slit lamp
Device class
Class I EUDAMED
Class II GUDID
Regulation number
886.1850
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
SL500
GUDID
SL500L
Device classEUDAMED
Class I
GUDID
Class II

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

Manufacturer details

EUDAMED SRN
FR-MF-000007175

Similar devices in this category

Other devices filed under SLIT LAMPS.

Other devices from Essilor International

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Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)