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Thd Pressprobe (Box)

by Thd S.P.A.

Ref 800141Model THD PRESSPROBE

Thd Pressprobe (Box) (800141) 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 24 Apr 2024 (Basic UDI-DI 803373771ANOPR00018T), cleared under FDA 510(k) K161785 on 14 Mar 2017 and listed in FDA GUDID since 20 Sep 2017 (UDI-DI 08033737711255), 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) K161785

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 Number803373771ANOPR00018T Basic UDI-DI 08033737711255UDI-DIDate24 Apr 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number08033737711255 UDI-DI Date20 Sep 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK161785 Date14 Mar 2017IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803373771ANOPR00018T registered 24 Apr 2024 Active
  • FDA 510(k) K161785 decided 14 Mar 2017 Active
  • FDA GUDID UDI-DI 08033737711255 listed 20 Sep 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K161785
  2. Listed FDA GUDID 08033737711255
  3. Registered EUDAMED 803373771ANOPR00018T

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  • Withdrawn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 Pressprobe (Box) EUDAMED
THD PressProbe GUDID
Generic name
Gastrointestinal motility manometric catheter, non-electronic
Model / Ref / Catalog
THD PRESSPROBE, 800141, THD PressProbe (Box)
Primary DI / UDI-DI
08033737711255
Basic UDI-DI
803373771ANOPR00018T
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
Weight — 25 Gram
Outer Diameter — 16 Millimeter
Length — 165 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
THD PRESSPROBE
800141
GUDID
THD PressProbe (Box)
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 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)