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Diagnostix™

by American Diagnostic Corporation 70 variants

Ref 5120NLV-02

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 Number063478251115211DK Basic UDI-DI 00634782087050UDI-DIDate26 Apr 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00634782087050 UDI-DI Date15 May 2019ListedStatusListed 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  • Withdrawn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
Ophthalmic/otologic diagnostic set
Device Name
Otoscope and parts
Model / Ref / Catalog
5120NLV-02 EUDAMED
5120NLV GUDID
Primary DI / UDI-DI
00634782087050
Basic UDI-DI
063478251115211DK
FDA Product Code
ERA
EMDN Code
Z12149006 Direct outpatient otoscopes
GMDN Term
Ophthalmic/otologic diagnostic set
Device Class
Class I
Regulation Number
874.4770
EU market of registration
Romania
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
5120NLV-02
GUDID
5120NLV

Manufacturer details

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

Other devices from American Diagnostic Corporation

See all devices from American Diagnostic Corporation →

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number

Other properties (21)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No