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Accutron Inc.

by Accutron 98 variants

Ref 53055Model Nasal Hood

Accutron Inc. (53055) is a device classified as Class IIa in the EU and Class I in the US made by Accutron, registered in EUDAMED on 8 Apr 2026 (Basic UDI-DI B-00813830027464) and listed in FDA GUDID since 22 Sep 2023 (UDI-DI 00813830027464), active as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US).

CE MDD

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 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00813830027464 Basic UDI-DI 00813830027464UDI-DIDate8 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00813830027464 UDI-DI Date22 Sep 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00813830027464 registered 8 Apr 2026 Active
  • FDA GUDID UDI-DI 00813830027464 listed 22 Sep 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00813830027464
  2. Registered EUDAMED B-00813830027464

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Accutron Inc. EUDAMED
Axess CapnographyAdapters GUDID
Generic name
Anaesthesia face mask, single-use
Model / Ref / Catalog
Nasal Hood, 53055
Primary DI / UDI-DI
00813830027464
Basic UDI-DI
B-00813830027464
FDA product code
KHA
EMDN code
Z1203010180 Anaesthesia systems - hardware accessories
GMDN term
Anaesthesia face mask, single-use
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
868.5590
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
US-MF-000009363
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Similar devices in this category

Other devices filed under ANAESTHESIA SYSTEMS - HARDWARE ACCESSORIES.

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Properties

  • Single use
  • Administering medicine
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)