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Thd Pressprobe (box)
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 800141Model THD PRESSPROBE
by Thd S.p.a.
Identity
- Trade Name
- THD PRESSPROBE (BOX) EUDAMEDTHD PressProbe FDA UDI
- Generic Name
- Gastrointestinal motility manometric catheter, non-electronic FDA UDI
- Device Name
- THD PRESSPROBE EUDAMEDTHD PressProbe is a disposable active probe for the execution of the THD Anal manometry exam. The probe allows the measurement of the real medium phincter tone pressure in the different functional activations (basal, squeeze and strain tones). THD PressProbe is meant to be used exclusively in combination with THD Anopress. The probe has an ergonomic grip and a completely atraumatic profile, which ensures the maximum comfort for both doctor and patient during the examintaion and it has been designed in order to reproduce a normal digital examination. Each pack contains a proprietary Probe Card, to enable the recording of the examination. FDA UDI
- Model / Reference
- THD PRESSPROBE EUDAMED800141 EUDAMEDTHD PressProbe (Box) FDA UDI
- Description
- THD PressProbe is a disposable active probe for the execution of the THD Anal manometry exam. The probe allows the measurement of the real medium phincter tone pressure in the different functional activations (basal, squeeze and strain tones). THD PressProbe is meant to be used exclusively in combination with THD Anopress. The probe has an ergonomic grip and a completely atraumatic profile, which ensures the maximum comfort for both doctor and patient during the examintaion and it has been designed in order to reproduce a normal digital examination. Each pack contains a proprietary Probe Card, to enable the recording of the examination. FDA UDI
Identifiers
- Catalog Number
- 800141 FDA UDI
- Primary DI / UDI-DI
- 08033737711255 EUDAMEDFDA UDI
- Basic UDI-DI
- 803373771ANOPR00018T EUDAMED
- 510(k) Number
- K161785 FDA UDI
- FDA Product Code
- KLA FDA UDI
- EMDN Code
- G02060305 COLORECTAL MANOMETRY CATHETERS EUDAMED
- GMDN Term
- Gastrointestinal motility manometric catheter, non-electronic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 876.1725 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
- Weight — 25 Gram FDA UDIOuter Diameter — 16 Millimeter FDA UDILength — 165 Millimeter FDA UDI
Thd Pressprobe (box) by Thd S.p.a. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 803373771ANOPR00018T | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Thd S.p.a.
- EUDAMED SRN
- IT-MF-000029427
Sources (2)
- EUDAMED 93e55f00-6ea9-4bb0-b2d2-b4f6b07b2f69 61 fields · synced Jul 10, 2026
- FDA UDI 11733d9d-263e-48ec-8d2b-2a14c419da55 37 fields · synced May 30, 2026