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Eup-C516

FDA UDI

Class II (US FDA UDI)

by FUJIFILM Corporation

Identity

Trade Name
EUP-C516 FDA UDI
Generic Name
Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Device Name
Probe FDA UDI
Model / Reference
EUP-C516 FDA UDI
Description
Probe FDA UDI

Identifiers

Primary DI / UDI-DI
04573596211564 FDA UDI
510(k) Number
K093466 FDA UDI
K102901 FDA UDI
FDA Product Code
IYO FDA UDI
IYN FDA UDI
ITX FDA UDI
GMDN Term
Extracorporeal ultrasound imaging transducer, hand-held FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
892.1560 FDA UDI
892.1550 FDA UDI
892.1570 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

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

Category: Extracorporeal ultrasound imaging transducer, hand-held

Eup-C516 by FUJIFILM Corporation — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Extracorporeal ultrasound imaging transducer, hand-held.

Cleared under the same submission

K093466 also covers:

K102901 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
FUJIFILM Corporation

Sources (1)

  • FDA UDI c9f1b97e-d2c5-4f3c-9132-f35b1f875ff8 35 fields · synced May 30, 2026