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Aseptico AEU-350S-W

by Aseptico, Inc.

Ref AEU-350S-WModel AEU-350

Aseptico AEU-350S-W is a device classified as Class IIa in the EU and Class I in the US made by Aseptico, Inc., registered in EUDAMED on 22 Dec 2025 (Basic UDI-DI 081741702dentalunitsX4) and listed in FDA GUDID since 16 Dec 2025 (UDI-DI 10817417020463), active as of 25 Oct 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 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number081741702dentalunitsX4 Basic UDI-DI 10817417020463UDI-DIDate22 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number10817417020463 UDI-DI Date16 Dec 2025ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 081741702dentalunitsX4 registered 22 Dec 2025 Active
  • FDA GUDID UDI-DI 10817417020463 listed 16 Dec 2025 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 10817417020463
  2. Registered EUDAMED 081741702dentalunitsX4

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  • Withdrawn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
Aseptico
Generic name
Dental delivery system
Model / Ref / Catalog
AEU-350S-W, AEU-350
Primary DI / UDI-DI
10817417020463
Basic UDI-DI
081741702dentalunitsX4
FDA product code
EIA
EMDN code
Q01010399 Dental medication devices - other
GMDN term
Dental delivery system
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.6640
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

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.

Similar devices in this category

Other devices filed under DENTAL IRRIGATION AND MEDICATION DEVICES.

Other devices from Aseptico, Inc.

See all devices from Aseptico, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
Other properties (22, all answered No)