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Nasometer II 6450

by PENTAX of America Inc. 2 variants

Nasometer II 6450 is a Class II device made by PENTAX of America Inc., registered in EUDAMED and listed in FDA GUDID since 6 Apr 2017 (UDI-DI 04961333229895), active as of 8 Nov 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 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number04961333229895 UDI-DI Date6 Apr 2017ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number— Date—StatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Active
  • FDA GUDID UDI-DI 04961333229895 listed 6 Apr 2017 Listed

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  • Withdrawn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
Nasometer II
Generic name
Electroglottograph
Model / reference
6450
Primary DI / UDI-DI
04961333229895
FDA product code
KLX
GMDN term
Electroglottograph
Device class
Class II
Regulation number
874.1325
GUDID distribution status
In Commercial Distribution

Related devices

Category: Electroglottograph

Other devices from PENTAX of America Inc.

See all devices from PENTAX of America Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Serial number
Other properties (12, all answered No)