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D-Actor® 200

by Storz Medical AG

Ref 19700.0103

D-Actor® 200 is a device classified as Class IIa in the EU and Class I in the US made by Storz Medical AG, registered in EUDAMED on 21 May 2026 (Basic UDI-DI B-07630039101039), cleared under FDA 510(k) K173692 on 13 Apr 2018 and listed in FDA GUDID since 28 May 2018 (UDI-DI 07630039101039), withdrawn (EUDAMED), active (FDA 510(k)) as of 25 Oct 2026.

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 Withdrawn in European Union.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

CE MDD, withdrawn 510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K173692

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-07630039101039 Basic UDI-DI 07630039101039UDI-DIDate21 May 2026RegisteredStatusWithdrawn
United StatesGUDID listing GUDID Number07630039101039 UDI-DI Date28 May 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK173692 Date13 Apr 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-07630039101039 registered 21 May 2026 Withdrawn
  • FDA 510(k) K173692 decided 13 Apr 2018 Active
  • FDA GUDID UDI-DI 07630039101039 listed 28 May 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K173692
  2. Listed FDA GUDID 07630039101039
  3. Registered EUDAMED B-07630039101039

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDD Withdrawn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

Specification

EUDAMED · GUDID

Trade name
D-Actor 200 EUDAMED
D-Actor® GUDID
Generic name
Hand-held electric massager
Model / reference
19700.0103 EUDAMED
200 GUDID
Primary DI / UDI-DI
07630039101039
Basic UDI-DI
B-07630039101039
510(k) Number
FDA product code
ISA
EMDN code
Z120622, Z12139001
GMDN term
Hand-held electric massager
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
890.5660
EU registration type
Legacy device (under a directive)
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
19700.0103
GUDID
200
Device classEUDAMED
Class IIa
GUDID
Class I

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: Hand-held electric massagerPressure-wave skin/body contouring system

Cleared under the same submission (K173692)

and 5 more cleared under K173692

Similar devices

Also classified as Pressure-wave skin/body contouring system.

Similar devices in this category

Other devices filed under SHOCK WAVE THERAPY EQUIPMENT.

Other devices from Storz Medical AG

See all devices from Storz Medical AG →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (20, all answered No)