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THD Anopress

by Thd SpA

Ref 800140

THD Anopress (800140) is a device classified as Class IIa in the EU and Class II in the US made by Thd SpA, registered in EUDAMED on 4 Nov 2026 (Basic UDI-DI 803373771ANOSYS001KV), cleared under FDA 510(k) K161785 on 14 Mar 2017 and listed in FDA GUDID since 14 Apr 2017 (UDI-DI 18033737711245), 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) K161785↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803373771ANOSYS001KV Basic UDI-DI 18033737711245UDI-DIDate4 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number18033737711245 UDI-DI Date14 Apr 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) 510(k) NumberK161785 Date14 Mar 2017IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 803373771ANOSYS001KV registered 4 Nov 2026 Active
  • FDA 510(k) K161785 decided 14 Mar 2017 Active
  • FDA GUDID UDI-DI 18033737711245 listed 14 Apr 2017 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K161785
  2. Listed FDA GUDID 18033737711245
  3. Registered EUDAMED 803373771ANOSYS001KV

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  • Withdrawn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 · 510(k) · GUDID

Generic name
Manometric gastrointestinal motility analysis system
Model / Ref / Catalog
800140, THD Anopress
Primary DI / UDI-DI
18033737711245
Basic UDI-DI
803373771ANOSYS001KV
510(k) Number
FDA product code
KLA
EMDN code
Z120701 Gastroenterological manometry equipment
GMDN term
Manometric gastrointestinal motility analysis system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
876.1725
System or procedure pack
System
EU registration type
System or procedure pack
Medical purpose
THD Anopress is an apparatus which assesses average sphincter tone and is used together with the THD Probes (THD PressProbe / THD SensyProbe). THD Anopress may be used in conjunction with a PC to record patient details and examination results.
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
800140
GUDID
THD Anopress
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: Manometric gastrointestinal motility analysis system

Cleared under the same submission (K161785)

and 2 more cleared under K161785

Similar devices in this category

Other devices filed under GASTROENTEROLOGICAL INSTRUMENTS.

Other devices from Thd SpA

See all devices from Thd SpA →

Properties

  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)