Identity
- Trade Name
- IC10-3 EUDAMED
- Device Name
- TRANSDUCER, IC10-3 EUDAMED
- Model / Reference
- TRANSDUCER, IC10-3 EUDAMEDP31039-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841517111182 EUDAMED
- Basic UDI-DI
- 08415171IC1035Y EUDAMED
- EMDN Code
- Z110402010201 CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- France EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Extracorporeal ultrasound imaging transducer, hand-held
Ic10-3 by Fujifilm Sonosite, Inc. — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08415171IC1035Y | Class IIa | Active |
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Manufacturer
- Manufacturer
- Fujifilm Sonosite, Inc.
- EUDAMED SRN
- US-MF-000001075
- Authorised Representative
- Fujifilm Sonosite B.V. NL-AR-000000046
Sources (1)
- EUDAMED 2d4cd253-35af-46f0-9951-a6838ee20215 61 fields · synced Jun 18, 2026