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P21n/5-1 MHz
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref P11879-70Model TRANSDUCER, P21N/5-1 MHZ, NANOMAXX
Identity
- Trade Name
- P21n/5-1 MHz EUDAMEDFDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- TRANSDUCER, P21N/5-1 MHZ, NANOMAXX EUDAMEDDiagnostic Ultrasound Transducer FDA UDI
- Model / Reference
- TRANSDUCER, P21N/5-1 MHZ, NANOMAXX EUDAMEDP11879-70 EUDAMEDFDA UDI
- Description
- Diagnostic Ultrasound Transducer FDA UDI
Identifiers
- Catalog Number
- P11879 FDA UDI
- Primary DI / UDI-DI
- 00841517100858 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841517100858 EUDAMED
- 510(k) Number
- K102390 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z110402010301 TRANSCUTANEOUS ULTRASOUND SECTOR PROBES (PHASED ARRAY), TWO–DIMENSIONAL 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
- 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
P21n/5-1 MHz by Fujifilm Sonosite, Inc. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-00841517100858 | 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 (2)
- EUDAMED 95c3107e-5025-4d33-aed4-e73da4e6c67f 61 fields · synced Jul 19, 2026
- FDA UDI e081638c-f6ea-4435-8fa9-53048c0134a1 37 fields · synced May 30, 2026