Identity
- Trade Name
- Transducer L12-4 EUDAMEDFDA UDITransducer L12-5 50 FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- Non-Invasive Transducers EUDAMED
- Model / Reference
- 989605396002 EUDAMEDFDA UDI989605430652 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838061484 EUDAMEDFDA UDI00884838061569 FDA UDI
- Basic UDI-DI
- 0884838BM428T4 EUDAMED
- FDA Product Code
- IYN FDA UDIITX FDA UDIIYO 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
- 892.1550 FDA UDI892.1570 FDA UDI892.1560 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
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
Transducer L12-4 by Philips Ultrasound LLC — 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 | 0884838BM428T4 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Philips Ultrasound LLC
- EUDAMED SRN
- US-MF-000002237
- Authorised Representative
- Philips Medical Systems Nederland B.V. NL-AR-000001422
Sources (3)
- EUDAMED e4ce4efe-3dc2-42a0-a85a-ba35f1a1ba8e 61 fields · synced Jun 8, 2026
- FDA UDI 788a9b72-1bb2-4eda-9070-b09a52468890 32 fields · synced May 30, 2026
- FDA UDI 84bc759e-ef57-4410-8532-9f4189742df3 32 fields · synced May 30, 2026