Transducer L12-3
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- Transducer L12-3 EUDAMEDTransducer L12-3 ERGO EUDAMEDL12-3 ERGO FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- Non-Invasive Transducers EUDAMED
- Model / Reference
- 989606710301 EUDAMED989605492481 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 00884838099142 EUDAMED00884838090804 EUDAMEDFDA UDI
- Basic UDI-DI
- 0884838BM428T4 EUDAMED
- FDA Product Code
- ITX FDA UDIIYO FDA UDIIYN FDA UDI
- EMDN Code
- Z110402010201 CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY) 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
No
Category: Extracorporeal ultrasound imaging transducer, hand-held
Transducer L12-3 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 8f216abb-b435-4717-b5de-336af6637f59 61 fields · synced Oct 6, 2026
- EUDAMED 19a3cadb-fb2f-413f-b497-d65cd7ae4db1 61 fields · synced May 17, 2026
- FDA UDI cca99b05-2bec-4a71-b3e2-e25317e007cd 32 fields · synced May 30, 2026