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ASonic

by Advance Medical Designs, Inc.

Ref ASG-001Model Advance Sonic Gel 20ML

ASonic (ASG-001) is a device classified as Class I in the EU and Class II in the US made by Advance Medical Designs, Inc., registered in EUDAMED on 7 Sep 2023 (Basic UDI-DI B-00848340014857), cleared under FDA 510(k) K163050 on 25 Oct 2017 and listed in FDA GUDID since 13 Jun 2023 (UDI-DI 00848340014857), active as of 7 Nov 2026.

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

CE MDR 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K163050

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-00848340014857 Basic UDI-DI 00848340014857UDI-DIDate7 Sep 2023RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-00848340014857 Basic UDI-DI 00848340014857UDI-DIDate7 Sep 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number00848340014857 UDI-DI Date13 Jun 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK163050 Date25 Oct 2017DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-00848340014857 registered 7 Sep 2023 Active· +1 more in the status table
  • FDA 510(k) K163050 decided 25 Oct 2017 Active
  • FDA GUDID UDI-DI 00848340014857 listed 13 Jun 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K163050
  2. Listed FDA GUDID 00848340014857
  3. Registered EUDAMED B-00848340014857

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ASonic EUDAMED
Asonic Gel GUDID
Generic name
Skin topical coupling gel
Device name
Advance Sonic Gel 20ML Packet
A Sonic Ultrasound Gel
Model / reference
ASG-001, Advance Sonic Gel 20ML
Primary DI / UDI-DI
00848340014857
Basic UDI-DI
B-00848340014857, 84834000ASG-0017U
Direct marketing DI
00848340014857
510(k) Number
FDA product code
MUI
EMDN code
Z11039099 Various radiodiagnostic and interventional instruments – other
GMDN term
Skin topical coupling gel
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1570
EU registration type
Legacy device (under a directive)
Standard device
EU market of registration
Germany
Belgium
GUDID distribution status
In Commercial Distribution
Sterilisation method
Radiation Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II
Supplied sterileEUDAMED
Yes
GUDID
No
Contains latexEUDAMED
Yes
GUDID
No

Registry differences

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

  • Supplied sterile UDI-DI 00848340014857: EUDAMED states Yes, FDA GUDID states No.
  • Contains latex UDI-DI 00848340014857: EUDAMED states Yes, FDA GUDID states No.

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.

Manufacturer details

EUDAMED SRN
US-MF-000009790
Authorised representative
MDSS GmbH DE-AR-000005430

Related devices

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Similar devices in this category

Other devices filed under VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS – OTHER.

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Properties

  • Supplied sterile YesEUDAMEDNoGUDID
  • Sterilise before use
  • Single use
  • Contains latex YesEUDAMEDNoGUDID
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)