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THD SensyProbe

FDA UDIEUDAMED

Class II (US FDA UDI)

by Thd Spa

Identity

Trade Name
THD SensyProbe FDA UDI
Generic Name
Gastrointestinal motility manometric catheter, non-electronic FDA UDI
Device Name
THD SensyProbe is an innovative single-use probe to be used with the Anopress device to perform a THD anorectal manometry examination. THD SensyProbe allows measuring of the actual mean sphincter tone pressure in the various functional activations (resting, squeeze and strain tone). In addition, thanks to a balloon fitted at the end of the probe and connection via a dedicated line, THD SensyProbe allows analysing the rectal ampulla volume and hence assessing rectal sensitivity and anorectal inhibitory reflex (this measurement can be made after inflating the balloon with the dedicated THD SensyProbe Accessory). THD SensyProbe does not need to be calibrated, as this is automatically done each time a procedure with THD Anopress is started. The probe is equipped with an ergonomic grip and has a fully atraumatic tip ensuring maximum comfort for the medical staff and the patient during the examination, and it has been dimensioned so as to reproduce the conditions during a normal digital exploration. A Probe Card to record the examination is included in the package. FDA UDI
Model / Reference
THD SensyProbe FDA UDI
Description
THD SensyProbe is an innovative single-use probe to be used with the Anopress device to perform a THD anorectal manometry examination. THD SensyProbe allows measuring of the actual mean sphincter tone pressure in the various functional activations (resting, squeeze and strain tone). In addition, thanks to a balloon fitted at the end of the probe and connection via a dedicated line, THD SensyProbe allows analysing the rectal ampulla volume and hence assessing rectal sensitivity and anorectal inhibitory reflex (this measurement can be made after inflating the balloon with the dedicated THD SensyProbe Accessory). THD SensyProbe does not need to be calibrated, as this is automatically done each time a procedure with THD Anopress is started. The probe is equipped with an ergonomic grip and has a fully atraumatic tip ensuring maximum comfort for the medical staff and the patient during the examination, and it has been dimensioned so as to reproduce the conditions during a normal digital exploration. A Probe Card to record the examination is included in the package. FDA UDI

Identifiers

Catalog Number
710010 FDA UDI
Primary DI / UDI-DI
08033737712290 FDA UDI
510(k) Number
K180135 FDA UDI
FDA Product Code
KLA FDA UDI
GMDN Term
Gastrointestinal motility manometric catheter, non-electronic FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
876.1725 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI

Dimensions & Sizes

Size
Length — 165 Millimeter FDA UDI
Outer Diameter — 16 Millimeter FDA UDI
Weight — 25 Gram FDA UDI

Category: Gastrointestinal motility manometric catheter, non-electronic

THD SensyProbe by Thd Spa — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Gastrointestinal motility manometric catheter, non-electronic.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Unknown

MDR

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Thd Spa

Sources (2)

  • FDA UDI 4b079b25-f351-4269-b443-1e836d7238b3 38 fields · synced Jun 19, 2026
  • EUDAMED 1 fields · synced Jun 4, 2026