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Aseptico AEU-525CF

by Aseptico, Inc.

Ref AEU-525CF

Aseptico AEU-525CF is a device classified as Class IIa in the EU and Class I in the US made by Aseptico, Inc., registered in EUDAMED on 26 Jul 2022 (Basic UDI-DI B-10817417020029), cleared under FDA 510(k) K130693 on 14 Aug 2013 and listed in FDA GUDID since 4 Apr 2017 (UDI-DI 10817417020029), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K130693

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-10817417020029 Basic UDI-DI 10817417020029UDI-DIDate26 Jul 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number10817417020029 UDI-DI Date4 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK130693 Date14 Aug 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-10817417020029 registered 26 Jul 2022 Active
  • FDA 510(k) K130693 decided 14 Aug 2013 Active
  • FDA GUDID UDI-DI 10817417020029 listed 4 Apr 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K130693
  2. Listed FDA GUDID 10817417020029
  3. Registered EUDAMED B-10817417020029

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Aseptico
Generic name
Ultrasonic dental scaling/debridement system
Device name
Transport III Portable Dental System: No handpieces
Model / Ref / Catalog
AEU-525CF
Primary DI / UDI-DI
10817417020029
Basic UDI-DI
B-10817417020029
510(k) Number
FDA product code
EIA, EKX, ELC
EMDN code
Q010399 Surgical dental devices - other
GMDN term
Ultrasonic dental scaling/debridement system
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.6640, 872.4200, 872.4850
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Size
Weight — 57 Pound

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I
Sterilise before useEUDAMED
Yes
GUDID
No

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 10817417020029: EUDAMED states Yes, FDA GUDID states No.

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.

Related devices

Category: Ultrasonic dental scaling/debridement system

Similar devices in this category

Other devices filed under SURGICAL DENTAL DEVICES - OTHER.

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See all devices from Aseptico, Inc. →

Properties

  • Sterilise before use YesEUDAMEDNoGUDID
  • Prescription use
  • Serial number
Other properties (20, all answered No)