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THD SensyProbe

by Thd SpA

Ref 710010

THD SensyProbe (710010) is a device classified as Class IIa in the EU and Class II in the US made by Thd SpA, registered in EUDAMED on 24 Apr 2024 (Basic UDI-DI 803373771ANOPR00028V), cleared under FDA 510(k) K180135 on 8 Mar 2018 and listed in FDA GUDID since 20 Mar 2018 (UDI-DI 08033737712290), 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) K180135

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 Number803373771ANOPR00028V Basic UDI-DI 08033737712290UDI-DIDate24 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08033737712290 UDI-DI Date20 Mar 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK180135 Date8 Mar 2018DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803373771ANOPR00028V registered 24 Apr 2024 Active
  • FDA 510(k) K180135 decided 8 Mar 2018 Active
  • FDA GUDID UDI-DI 08033737712290 listed 20 Mar 2018 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K180135
  2. Listed FDA GUDID 08033737712290
  3. Registered EUDAMED 803373771ANOPR00028V

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  • Withdrawn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
Gastrointestinal motility manometric catheter, non-electronic
Model / Ref / Catalog
710010, THD SensyProbe
Primary DI / UDI-DI
08033737712290
Basic UDI-DI
803373771ANOPR00028V
510(k) Number
FDA product code
KLA
EMDN code
G02060305 Colorectal manometry catheters
GMDN term
Gastrointestinal motility manometric catheter, non-electronic
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1725
EU registration type
Standard device
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Length — 165 Millimeter
Outer Diameter — 16 Millimeter
Weight — 25 Gram

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
710010
GUDID
THD SensyProbe
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: Gastrointestinal motility manometric catheter, non-electronic

Similar devices in this category

Other devices filed under DEVICES FOR COLORECTAL DIAGNOSTIC PROCEDURES.

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Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (21, all answered No)