Identity
- Trade Name
- L4-20t-RS EUDAMEDNA FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- L4-20t-RS EUDAMEDFDA UDI
- Model / Reference
- 5851518 EUDAMEDH48062AJ EUDAMEDL4-20t-RS FDA UDI
- Description
- L4-20t-RS FDA UDI
Identifiers
- Catalog Number
- H48062AJ FDA UDI
- Primary DI / UDI-DI
- 00840682190299 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00316HA EUDAMED
- Direct Marketing DI
- 00840682190299 EUDAMED
- 510(k) Number
- K202233 FDA UDI
- FDA Product Code
- IYO FDA UDIIYN FDA UDIITX 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
- 892.1560 FDA UDI892.1550 FDA UDI892.1570 FDA UDI
- Market of Registration
- France 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
No
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
No
Category: Extracorporeal ultrasound imaging transducer, hand-held
L4-20t-RS by GE Medical Systems CO. Ltd — 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 | 8406821BUG00316HA | 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
- GE Medical Systems CO. Ltd
- EUDAMED SRN
- CN-MF-000001856
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED de4220c5-50f4-4cc8-8655-94d5fe00a64f 61 fields · synced Oct 6, 2026
- FDA UDI 7b42832a-4e4b-4ab6-a7df-2eb9ed30b274 37 fields · synced May 30, 2026