Identity
- Trade Name
- THD Anopress FDA UDI
- Generic Name
- Manometric gastrointestinal motility analysis system FDA UDI
- Device Name
- THD Anopress is a portable system that allows the execution of the anal manometry in an easy and standardized way, by measuring the pressure data of the sphincterial cylinder in different phases: rest, squeeze, strain and endurance. THD Anopris practical and easy to use, compact, light and easily transportable. It is suitable for immediate use both in outpatient clinic and hospital. It is provided with a 3.5" color display that allows to visualize both the pressure values and the relevant curves. THD Anopress is operated by rechargeable batteries whose charge lasts approximately 5 hours. Through the Bluetooth connection, THD Anopress is able to register the exam over a dedicated software. FDA UDI
- Model / Reference
- THD Anopress FDA UDI
- Description
- THD Anopress is a portable system that allows the execution of the anal manometry in an easy and standardized way, by measuring the pressure data of the sphincterial cylinder in different phases: rest, squeeze, strain and endurance. THD Anopris practical and easy to use, compact, light and easily transportable. It is suitable for immediate use both in outpatient clinic and hospital. It is provided with a 3.5" color display that allows to visualize both the pressure values and the relevant curves. THD Anopress is operated by rechargeable batteries whose charge lasts approximately 5 hours. Through the Bluetooth connection, THD Anopress is able to register the exam over a dedicated software. FDA UDI
Identifiers
- Catalog Number
- 800160 FDA UDI
- Primary DI / UDI-DI
- 18033737711412 FDA UDI
- 510(k) Number
- K161785 FDA UDI
- FDA Product Code
- KLA FDA UDI
- GMDN Term
- Manometric gastrointestinal motility analysis system 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
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
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
Category: Manometric gastrointestinal motility analysis system
THD Anopress by Thd Spa — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K161785 also covers:
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Thd Spa
Sources (1)
- FDA UDI 0afbed40-5fd8-46cf-af01-254f6417ab65 36 fields · synced May 30, 2026