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Diagnostix™

by American Diagnostic Corporation 70 variants

Part of a family of 16 devices: see the family page

Ref 5410X

Diagnostix™ (5410X) is a Class I device made by American Diagnostic Corporation, registered in EUDAMED on 26 Apr 2023 (Basic UDI-DI 063478251005699EP), cleared under FDA 510(k) K932506 on 8 Oct 1993 and listed in FDA GUDID since 21 Sep 2016 (UDI-DI 00634782076528), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K932506

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number063478251005699EP Basic UDI-DI 00634782076528UDI-DIDate26 Apr 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00634782076528 UDI-DI Date21 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK932506 Date8 Oct 1993DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 063478251005699EP registered 26 Apr 2023 Active
  • FDA 510(k) K932506 decided 8 Oct 1993 Active
  • FDA GUDID UDI-DI 00634782076528 listed 21 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K932506
  2. Listed FDA GUDID 00634782076528
  3. Registered EUDAMED 063478251005699EP

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Ophthalmic/otologic diagnostic set
Device name
Ophthalmoscope and parts
Model / Ref / Catalog
5410X
Primary DI / UDI-DI
00634782076528
Basic UDI-DI
063478251005699EP
510(k) Number
FDA product code
ERA
EMDN code
Z12040102, Z12120114, Z12149006
GMDN term
Ophthalmic/otologic diagnostic set
Device class
Class I
Regulation number
874.4770
EU registration type
Standard device
EU market of registration
Romania
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
US-MF-000021544
Authorised representative
S.C. Cattus S.R.L. RO-AR-000020096

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Properties

  • Over-the-counter
  • Convenience kit
  • Lot / batch number
Other properties (22, all answered No)