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Phonatory Aerodynamic System 6615

by PENTAX of America Inc.

Ref 6615

Phonatory Aerodynamic System 6615 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 496133303A6615VE) and listed in FDA GUDID since 7 Apr 2017 (UDI-DI 04961333231034), 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, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 8 Nov 2026.

Regulatory status

as of registry sync 8 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number496133303A6615VE Basic UDI-DI 04961333231034UDI-DIDate11 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04961333231034 UDI-DI Date7 Apr 2017ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 496133303A6615VE registered 11 May 2026 Active
  • FDA GUDID UDI-DI 04961333231034 listed 7 Apr 2017 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 04961333231034
  2. Registered EUDAMED 496133303A6615VE

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  • Withdrawn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
Pediatric Disposable Masks EUDAMED
Phonatory Aerodynamic System GUDID
Generic name
Electroglottograph
Model / reference
6615
Primary DI / UDI-DI
04961333231034
Basic UDI-DI
496133303A6615VE
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

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
Other properties (21, all answered No)