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PIEZOWAVE2 100506

by Richard Wolf GmbH

Ref 100506Model 10000201211

PIEZOWAVE2 100506 is a medical device (EU MDD Class IIb; FDA Class I; FDA product code ISA, Massager, therapeutic, electric; EMDN category shock wave therapy equipment) made by Richard Wolf GmbH, registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI B-04055207063989) and listed in FDA GUDID since 14 Feb 2022 (UDI-DI 04055207063989), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-04055207063989 Basic UDI-DI 04055207063989UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04055207063989 UDI-DI Date14 Feb 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-04055207063989 registered 5 Oct 2026 Active
  • FDA GUDID UDI-DI 04055207063989 listed 14 Feb 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 04055207063989
  2. Registered EUDAMED B-04055207063989

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  • Withdrawn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
PIEZOWAVE2
Generic name
Electromechanical orthopaedic extracorporeal shock wave therapy system
Device name
Therapy sources for ESWT
Model / Ref / Catalog
100506, 10000201211
Primary DI / UDI-DI
04055207063989
Basic UDI-DI
B-04055207063989
FDA product code
ISA
EMDN code
Z12139001 Shock wave therapy equipment
GMDN term
Electromechanical orthopaedic extracorporeal shock wave therapy system
Device class
Class IIb EUDAMED
Class I GUDID
Regulation number
890.5660
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class I

Device class is stated on each registry's own scale: Class IIb 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: Electromechanical orthopaedic extracorporeal shock wave therapy system

Similar devices in this category

Other devices filed under SHOCK WAVE THERAPY EQUIPMENT.

Other devices from Richard Wolf GmbH

See all devices from Richard Wolf GmbH →

Properties

  • Premarket exempt
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)