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Pressure Sensor

by Thought Technology, Ltd.

Ref SA9003

Pressure Sensor (SA9003) is a device classified as Class I in the EU and Class II in the US made by Thought Technology Ltd., registered in EUDAMED on 19 May 2022 (Basic UDI-DI 75401910006099), cleared under FDA 510(k) K201014 on 13 Jan 2021 and listed in FDA GUDID since 23 Mar 2022 (UDI-DI 07540191000609), active as of 22 Oct 2026.

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

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K201014

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number75401910006099 Basic UDI-DI 07540191000609UDI-DIDate19 May 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number07540191000609 UDI-DI Date23 Mar 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK201014 Date13 Jan 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 75401910006099 registered 19 May 2022 Active
  • FDA 510(k) K201014 decided 13 Jan 2021 Active
  • FDA GUDID UDI-DI 07540191000609 listed 23 Mar 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K201014
  2. Listed FDA GUDID 07540191000609
  3. Registered EUDAMED 75401910006099

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Generic name
Psychophysiological biofeedback system
Model / reference
SA9003
Primary DI / UDI-DI
07540191000609
Basic UDI-DI
75401910006099
510(k) Number
FDA product code
HCC
EMDN code
U070399 Pelvic floor rehabilitation devices - other
GMDN term
Psychophysiological biofeedback system
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.5050
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

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
CA-MF-000024010
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under PELVIC FLOOR REHABILITATION DEVICES - OTHER.

Other devices from Thought Technology Ltd.

See all devices from Thought Technology Ltd. →

Properties

  • Prescription use
  • Lot / batch number
  • Manufacturing date
Other properties (22, all answered No)