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Thd 4K Cam

by Thd S.P.A.

Ref 800195

Thd 4K Cam (800195) is an ultrasound imaging system application software (EU MDR Class I; FDA Class II) made by Thd S.P.A., registered in EUDAMED on 29 Nov 2023 (Basic UDI-DI 803373771CAM001Z2), cleared under FDA 510(k) K211623 on 24 Jun 2021 and listed in FDA GUDID since 7 Oct 2022 (UDI-DI 18033737712341), 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) K211623

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 Number803373771CAM001Z2 Basic UDI-DI 18033737712341UDI-DIDate29 Nov 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number18033737712341 UDI-DI Date7 Oct 2022ListedStatusListed 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 803373771CAM001Z2 registered 29 Nov 2023 Active
  • FDA 510(k) K211623 decided 24 Jun 2021 Active
  • FDA GUDID UDI-DI 18033737712341 listed 7 Oct 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K211623
  2. Listed FDA GUDID 18033737712341
  3. Registered EUDAMED 803373771CAM001Z2

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  • Withdrawn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 4K Cam EUDAMED
THD Procto Software System GUDID
Generic name
Ultrasound imaging system application software
Model / Ref / Catalog
800195, THD 4K CAM
Primary DI / UDI-DI
18033737712341
Basic UDI-DI
803373771CAM001Z2
510(k) Number
FDA product code
IYO, KLA, ITX, FWG, OUG, NSX
EMDN code
Z12020405 Surgical cameras
GMDN term
Ultrasound imaging system application software
Device class
Class I EUDAMED
Class II GUDID
Regulation number
892.1560, 876.1725, 892.1570, 878.4160, 880.6310
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
800195
GUDID
THD 4K CAM
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
IT-MF-000029427

Similar devices in this category

Other devices filed under SURGICAL CAMERAS.

Other devices from Thd S.P.A.

See all devices from Thd S.P.A. →

Properties

  • Prescription use
  • Convenience kit
  • Serial number
Other properties (22, all answered No)