Identity
- Trade Name
- P5-1 EUDAMEDP5-1 TRANSDUCER FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- TRANSDUCER, P5-1 EUDAMEDP5-1 Transducer FDA UDI
- Model / Reference
- TRANSDUCER, P5-1 EUDAMEDP24087-22 EUDAMEDFDA UDI
- Description
- P5-1 Transducer FDA UDI
Identifiers
- Catalog Number
- P24087 FDA UDI
- Primary DI / UDI-DI
- 00841517106379 EUDAMEDFDA UDI
- Basic UDI-DI
- B-00841517106379 EUDAMED
- 510(k) Number
- K200964 FDA UDI
- FDA Product Code
- IYN FDA UDIITX FDA UDIOIJ FDA UDIIYO 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
- 892.1550 FDA UDI892.1570 FDA UDI892.1560 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
P5-1 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-00841517106379 | 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 253d53d9-aa0b-42f0-b8d4-bb1f03cb2ec7 61 fields · synced Jul 9, 2026
- FDA UDI 7a5f3d52-6ae7-4058-a0e1-daed79bf5066 36 fields · synced May 30, 2026