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L38xi/10-5 MHz Armored
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P30371-02Model TRANSDUCER, L38XI/10-5 MHZRef P19626-10
Identity
- Trade Name
- L38xi/10-5 MHz Armored EUDAMEDFDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- TRANSDUCER, L38XI/10-5 MHZ EUDAMEDDiagnostic Ultrasound Transducer FDA UDI
- Model / Reference
- TRANSDUCER, L38XI/10-5 MHZ EUDAMEDP30371-02 EUDAMEDP19626-10 EUDAMEDFDA UDI
- Description
- Diagnostic Ultrasound Transducer FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00841517111076 EUDAMED00841517100452 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415171L38XI9S EUDAMED
- FDA Product Code
- ITX 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
- 892.1570 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
L38xi/10-5 MHz Armored by Fujifilm Sonosite, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08415171L38XI9S | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
- EUDAMED SRN
- US-MF-000001075
- Authorised Representative
- Fujifilm Sonosite B.V. NL-AR-000000046
Sources (3)
- EUDAMED 94345897-39fd-4b86-b2c7-ea033fead285 61 fields · synced Aug 4, 2026
- EUDAMED b1292d59-c4ac-4788-9d2c-98867476d871 61 fields · synced May 18, 2026
- FDA UDI 279f641c-f7fd-4143-bdd9-7d8b0b4a1b52 36 fields · synced May 30, 2026