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Powerx 115-0031

by Solta Medical, Inc.

Ref 115-0031

Powerx 115-0031 is a device classified as Class IIa in the EU and Class II in the US made by Solta Medical, Inc., registered in EUDAMED on 12 May 2026 (Basic UDI-DI B-00816995021605) and listed in FDA GUDID since 6 Apr 2022 (UDI-DI 00816995021605), 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-00816995021605 Basic UDI-DI 00816995021605UDI-DIDate12 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00816995021605 UDI-DI Date6 Apr 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00816995021605 registered 12 May 2026 Active
  • FDA GUDID UDI-DI 00816995021605 listed 6 Apr 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00816995021605
  2. Registered EUDAMED B-00816995021605

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  • Withdrawn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
Powerx
Generic name
Ultrasonic surgical system generator
Device name
Mendieta Kit for PowerX®
Model / Ref / Catalog
115-0031
Primary DI / UDI-DI
00816995021605
Basic UDI-DI
B-00816995021605
FDA product code
QPB
EMDN code
L250399 Liposuction instruments, reusable - other
GMDN term
Ultrasonic surgical system generator
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
878.5040
EU registration type
Legacy device (under a directive)
EU market of registration
Netherlands
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 II

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.

Similar devices in this category

Other devices filed under LIPOSUCTION INSTRUMENTS, REUSABLE - OTHER.

Other devices from Solta Medical, Inc.

See all devices from Solta Medical, Inc. →

Properties

  • Sterilise before use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Manufacturing date
Other properties (18, all answered No)