Identity
- Trade Name
- ML4-20VN-D EUDAMEDNA FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- ML4-20 probes family EUDAMEDML4-20VN-D EUDAMEDFDA UDI
- Model / Reference
- 5838851 EUDAMEDML4-20VN-D EUDAMEDFDA UDI
- Description
- ML4-20VN-D FDA UDI
Identifiers
- Catalog Number
- H44901AU FDA UDI
- Primary DI / UDI-DI
- 00195278002730 EUDAMEDFDA UDI
- Basic UDI-DI
- 8406821BUG00337HJ EUDAMEDB-00195278002730 EUDAMED
- 510(k) Number
- K211524 FDA UDI
- FDA Product Code
- ITX FDA UDIIYN FDA UDIIYO FDA UDI
- EMDN Code
- Z110402010101 TWO–DIMENSIONAL LINEAR–ARRAY TRANSCUTANEOUS ULTRASOUND PROBES EUDAMEDZ110402010302 TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), MULTIDIMENSIONAL 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 UDI892.1550 FDA UDI892.1560 FDA UDI
- Market of Registration
- France EUDAMEDAustria 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
Ml4-20vn-D by GE Parallel Design, Inc. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 8406821BUG00337HJ | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 8406821BUG00337HJ | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- GE Parallel Design, Inc.
- EUDAMED SRN
- US-MF-000009295
- Authorised Representative
- GE Medical Systems SCS FR-AR-000000344
Sources (3)
- EUDAMED 356a53c2-1aa7-4dd3-aa43-3f53c54fe2d0 61 fields · synced Jul 24, 2026
- EUDAMED 69a22cb2-5c83-4f87-9c82-d57e0407a637 61 fields · synced May 19, 2026
- FDA UDI fd978af2-6f3e-41e3-995c-c389d58a3a03 37 fields · synced May 29, 2026