Identity
- Trade Name
- L12-3 EUDAMEDFDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- TRANSDUCER, L12-3 EUDAMEDDiagnostic Ultrasound Transducer FDA UDI
- Model / Reference
- TRANSDUCER, L12-3 EUDAMEDP22916-21A EUDAMEDFDA UDI
- Description
- Diagnostic Ultrasound Transducer FDA UDI
Identifiers
- Catalog Number
- P22916 FDA UDI
- Primary DI / UDI-DI
- 00841517110536 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415171L123BK EUDAMED
- 510(k) Number
- K213763 FDA UDI
- FDA Product Code
- ITX FDA UDIIYO FDA UDIIYN FDA UDI
- EMDN Code
- Z110402010101 TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES EUDAMED
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1570 FDA UDI892.1560 FDA UDI892.1550 FDA UDI
- Market of Registration
- Germany 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
L12-3 by Fujifilm Sonosite, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Extracorporeal ultrasound imaging transducer, hand-held.
- 6C2 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Biim Android App, P1.3 — Biim Ultrasound AS · Class II
- C6-2 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- Battery Charger AU, Biim Ultrasound — Biim Ultrasound AS · Class II
- SonoScape — SONOSCAPE MEDICAL CORP. · Class II
- 4C1 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- UST-5419 — FUJIFILM Corporation · Class II
- P4-12 — SAMSUNG MEDISON CO., LTD · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08415171L123BK | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
- EUDAMED SRN
- US-MF-000001075
- Authorised Representative
- Fujifilm Sonosite B.V. NL-AR-000000046
Sources (2)
- EUDAMED f0ffb1e3-6d0f-46ed-825b-d125af9afad8 61 fields · synced Jul 20, 2026
- FDA UDI 8399bfb5-aa28-4b0b-bc69-cc98e1fdde11 36 fields · synced May 30, 2026