Identity
- Trade Name
- T8-3 EUDAMEDFDA UDI
- Generic Name
- Oesophageal ultrasound imaging transducer, reusable FDA UDI
- Device Name
- TRANSDUCER, T8-3 EUDAMEDDiagnostic ultrasound transducer FDA UDI
- Model / Reference
- TRANSDUCER, T8-3 EUDAMEDP29465-21 EUDAMEDFDA UDI
- Description
- Diagnostic ultrasound transducer FDA UDI
Identifiers
- Catalog Number
- P29465 FDA UDI
- Primary DI / UDI-DI
- 00841517109400 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415171T83S2 EUDAMED
- 510(k) Number
- K213763 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO FDA UDI
- EMDN Code
- Z110402010101 TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES EUDAMED
- GMDN Term
- Oesophageal ultrasound imaging transducer, reusable FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1550 FDA UDI892.1560 FDA UDI
- Market of Registration
- Denmark EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Extracorporeal ultrasound imaging transducer, hand-held
T8-3 by Fujifilm Sonosite, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08415171T83S2 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
- EUDAMED SRN
- US-MF-000001075
- Authorised Representative
- Fujifilm Sonosite B.V. NL-AR-000000046
Sources (2)
- EUDAMED c218f2a7-6349-450c-92fa-8130b971df90 61 fields · synced Jul 11, 2026
- FDA UDI 985e2f7b-911a-469a-ae6f-02dff677bff0 36 fields · synced May 30, 2026