Identity
- Trade Name
- L3-12-D EUDAMEDNA FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- L3-12-D EUDAMED
- Model / Reference
- 5437242 EUDAMEDH48062AA EUDAMEDL3-12-D FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00840682105064 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00315H8 EUDAMED
- Direct Marketing DI
- 00840682105064 EUDAMED
- 510(k) Number
- K160182 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
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
L3-12-D by GE Medical Systems CO. Ltd — 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 | 8406821BUG00315H8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GE Medical Systems CO. Ltd
- EUDAMED SRN
- CN-MF-000001856
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (2)
- EUDAMED d5cb482a-5ee4-42e1-a4a6-f5119b8f161c 61 fields · synced Jun 19, 2026
- FDA UDI aecfbc9d-c48c-4e88-aa58-02ca5572f1a3 34 fields · synced May 27, 2026