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Thd Slide

by Thd S.P.A.

Ref 710004Model THD SLIDE

Thd Slide (710004) is a device classified as Class IIa in the EU and Class II in the US made by Thd S.P.A., registered in EUDAMED on 23 Apr 2024 (Basic UDI-DI 803373771KIT0001D8), cleared under FDA 510(k) K090009 on 28 Jan 2009 and listed in FDA GUDID since 30 Oct 2025 (UDI-DI 08033737710869), active as of 23 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K090009

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08033737710869 UDI-DI Date30 Oct 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number803373771KIT0001D8 Basic UDI-DI 08033737710869UDI-DIDate23 Apr 2024RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK090009 Date28 Jan 2009DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803373771KIT0001D8 registered 23 Apr 2024 Active
  • FDA 510(k) K090009 decided 28 Jan 2009 Active
  • FDA GUDID UDI-DI 08033737710869 listed 30 Oct 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K090009
  2. Registered EUDAMED 803373771KIT0001D8
  3. Listed FDA GUDID 08033737710869

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  • Withdrawn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 Slide EUDAMED
Thd Slide One GUDID
Generic name
Optical proctoscope, single-use
Model / Ref / Catalog
THD SLIDE, 710004
Primary DI / UDI-DI
08033737710869
Basic UDI-DI
803373771KIT0001D8
510(k) Number
FDA product code
JAF
EMDN code
Z12020604 Ultrasonic proctoscopes
GMDN term
Optical proctoscope, single-use
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
892.1540
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
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.

Manufacturer details

EUDAMED SRN
IT-MF-000029427

Similar devices in this category

Other devices filed under LOWER GASTROINTESTINAL TRACT ENDOSCOPY INSTRUMENTS.

Other devices from Thd S.P.A.

See all devices from Thd S.P.A. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (20, all answered No)