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Cp 550

by Essilor International

Ref CP550

Cp 550 (CP550) is a Class I device made by Essilor International, registered in EUDAMED on 18 Aug 2025 (Basic UDI-DI 361502000000ICP55000000HN) and listed in FDA GUDID since 23 Feb 2026 (UDI-DI 03615020000113), 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
United StatesGUDID listing GUDID Number03615020000113 UDI-DI Date23 Feb 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number361502000000ICP55000000HN Basic UDI-DI 03615020000113UDI-DIDate18 Aug 2025RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 361502000000ICP55000000HN registered 18 Aug 2025 Active
  • FDA GUDID UDI-DI 03615020000113 listed 23 Feb 2026 Listed

Timeline

2 dated events

  1. Registered EUDAMED 361502000000ICP55000000HN
  2. Listed FDA GUDID 03615020000113

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  • Withdrawn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
Visual acuity projector
Model / reference
CP550
Primary DI / UDI-DI
03615020000113
Basic UDI-DI
361502000000ICP55000000HN
FDA product code
HOS
EMDN code
Z1212012001 Visual functional assessment equipment
GMDN term
Visual acuity projector
Device class
Class I
Regulation number
886.1680
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
FR-MF-000007175

Similar devices in this category

Other devices filed under VISUAL FUNCTIONAL ASSESSMENT EQUIPMENT.

Other devices from Essilor International

See all devices from Essilor International →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)