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MicroAire® ASP-ADP-3

by MicroAire Surgical Instruments LLC

Ref ASP-ADP-3

MicroAire® ASP-ADP-3 is a device classified as Class IIa in the EU and Class II in the US made by MicroAire Surgical Instruments LLC, registered in EUDAMED on 10 Sep 2026 (Basic UDI-DI B-00847399006431), listed under FDA premarket submission BK220674 and listed in FDA GUDID since 23 Aug 2022 (UDI-DI 00847399006431), active as of 24 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 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) BK220674

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00847399006431 Basic UDI-DI 00847399006431UDI-DIDate10 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00847399006431 UDI-DI Date23 Aug 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberBK220674 Date—StatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00847399006431 registered 10 Sep 2026 Active
  • FDA premarket submission BK220674 Active
  • FDA GUDID UDI-DI 00847399006431 listed 23 Aug 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00847399006431
  2. Registered EUDAMED B-00847399006431

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  • Withdrawn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
Adapter, Toomey-to-Luer Needle EUDAMED
MicroAire® GUDID
Generic name
Collection syringe adaptor, single-use
Model / reference
ASP-ADP-3
Primary DI / UDI-DI
00847399006431
Basic UDI-DI
B-00847399006431
FDA product code
MUU
EMDN code
X0401 Equipment without an intended medical purpose for liposuction
GMDN term
Collection syringe adaptor, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.5040
EU registration type
Legacy device (under a directive)
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
Supplied sterileEUDAMED
Yes
GUDID
No
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

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

  • Supplied sterile UDI-DI 00847399006431: EUDAMED states Yes, FDA GUDID states No.
  • Sterilise before use UDI-DI 00847399006431: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIa 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: Collection syringe adaptor, single-use

Cleared under the same submission (BK220674)

Similar devices in this category

Other devices filed under EQUIPMENT WITHOUT AN INTENDED MEDICAL PURPOSE INTENDED TO BE USED TO REDUCE, REMOVE OR DESTROY ADIPOSE TISSUE.

Other devices from MicroAire Surgical Instruments LLC

See all devices from MicroAire Surgical Instruments LLC →

Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Sterilise before use NoEUDAMEDYesGUDID
  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)