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THD Procto Software System

by Thd SpA

Ref 760004

THD Procto Software System (760004) is a device classified as Class IIa in the EU and Class II in the US made by Thd SpA, registered in EUDAMED on 23 Apr 2024 (Basic UDI-DI 803373771PROSW001BA), cleared under FDA 510(k) K211623 on 24 Jun 2021 and listed in FDA GUDID since 19 Jul 2021 (UDI-DI 08033737713037), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K211623

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 Number803373771PROSW001BA Basic UDI-DI 08033737713037UDI-DIDate23 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08033737713037 UDI-DI Date19 Jul 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK211623 Date24 Jun 2021DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803373771PROSW001BA registered 23 Apr 2024 Active
  • FDA 510(k) K211623 decided 24 Jun 2021 Active
  • FDA GUDID UDI-DI 08033737713037 listed 19 Jul 2021 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K211623
  2. Listed FDA GUDID 08033737713037
  3. Registered EUDAMED 803373771PROSW001BA

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  • Withdrawn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

Trade name
Thd Procto Software EUDAMED
THD Procto Software System GUDID
Generic name
Ultrasound imaging system application software
Model / Ref / Catalog
760004, THD Procto Software
Primary DI / UDI-DI
08033737713037
Basic UDI-DI
803373771PROSW001BA
510(k) Number
FDA product code
IYO, KLA, ITX, FWG, OUG, NSX
EMDN code
Z12020692 Lower gastrointestinal tract endoscopy instruments - medical device software
GMDN term
Ultrasound imaging system application software
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1560, 876.1725, 892.1570, 878.4160, 880.6310
Special device type
Software
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
760004
GUDID
THD Procto Software
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.

Related devices

Category: Ultrasound imaging system application software

Cleared under the same submission (K211623)

and 3 more cleared under K211623

Similar devices in this category

Other devices filed under LOWER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS.

Other devices from Thd SpA

See all devices from Thd SpA →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)