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THD SensyProbe AX
EUDAMEDFDA UDIClass I (EU MDR)
Ref 750032Model THD SensyProbe Accessory
by Thd S.p.a.
Identity
- Trade Name
- THD SensyProbe AX EUDAMEDTHD SensyProbe FDA UDI
- Generic Name
- Gastrointestinal motility manometric catheter, non-electronic FDA UDI
- Device Name
- THD SensyProbe Accessory EUDAMEDTHD SensyProbe Accessory consists of a syringe and a 3-way stopcock. The syringe is provided with a male luer lock that allows the connection to the THD SensyProbe inflation line. FDA UDI
- Model / Reference
- THD SensyProbe Accessory EUDAMEDFDA UDI750032 EUDAMED
- Description
- THD SensyProbe Accessory consists of a syringe and a 3-way stopcock. The syringe is provided with a male luer lock that allows the connection to the THD SensyProbe inflation line. FDA UDI
Identifiers
- Catalog Number
- 750032 FDA UDI
- Primary DI / UDI-DI
- 08033737712306 EUDAMEDFDA UDI
- Basic UDI-DI
- 803373771ANOACC0001GM EUDAMED
- 510(k) Number
- K180135 FDA UDI
- FDA Product Code
- KLA FDA UDI
- EMDN Code
- A0280 SYRINGES - ACCESSORIES EUDAMED
- GMDN Term
- Gastrointestinal motility manometric catheter, non-electronic FDA UDI
Classification
- Device Class
- Class I 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
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Dimensions & Sizes
- Size
- Total Volume — 60 Milliliter FDA UDI
THD SensyProbe AX by Thd S.p.a. — Class I — 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 | 803373771ANOACC0001GM | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Thd S.p.a.
- EUDAMED SRN
- IT-MF-000029427
Sources (2)
- EUDAMED e68fd82e-ccff-499b-a052-1ff16004d6ce 61 fields · synced Jun 18, 2026
- FDA UDI 2feed46c-9440-4cc6-84e6-3564ed60ffe3 37 fields · synced May 30, 2026