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Phonatory Aerodynamic System 6613

by PENTAX of America Inc.

Ref 6613Model 6610

Phonatory Aerodynamic System 6613 is a device classified as Class I in the EU and Class II in the US made by PENTAX of America Inc., registered in EUDAMED on 11 May 2026 (Basic UDI-DI 496133303A6610V4) and listed in FDA GUDID since 7 Apr 2017 (UDI-DI 04961333230129), 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
European UnionCE/MDR EUDAMED Number496133303A6610V4 Basic UDI-DI 04961333230129UDI-DIDate11 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04961333230129 UDI-DI Date7 Apr 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 496133303A6610V4 registered 11 May 2026 Active
  • FDA GUDID UDI-DI 04961333230129 listed 7 Apr 2017 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04961333230129
  2. Registered EUDAMED 496133303A6610V4

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  • Withdrawn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
Airflow Head‑Mask Couplers EUDAMED
Phonatory Aerodynamic System GUDID
Generic name
Electroglottograph
Device name
Cardboard Tubes (Disposable)
Model / reference
6613, 6610
Primary DI / UDI-DI
04961333230129
Basic UDI-DI
496133303A6610V4
FDA product code
KLX
EMDN code
Z12149080 Various ENT instruments - hardware accessories
GMDN term
Electroglottograph
Device class
Class I EUDAMED
Class II GUDID
Regulation number
874.1325
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Related devices

Category: Electroglottograph

Similar devices in this category

Other devices filed under VARIOUS ENT INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from PENTAX of America Inc.

See all devices from PENTAX of America Inc. →

Properties

  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)