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C10-3
EUDAMEDClass IIa (EU MDR)
Ref P31043-02Model TRANSDUCER, C10-3Ref P31043-01
Identity
- Trade Name
- C10-3 EUDAMED
- Device Name
- TRANSDUCER, C10-3 EUDAMED
- Model / Reference
- TRANSDUCER, C10-3 EUDAMEDP31043-02 EUDAMEDP31043-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 00841517111229 EUDAMED00841517108267 EUDAMED
- Basic UDI-DI
- 008415171C103S3 EUDAMEDB-00841517108267 EUDAMED
- EMDN Code
- Z110402010201 CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Belgium 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
C10-3 by Fujifilm Sonosite, Inc. — Class IIa — MDD, 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/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 008415171C103S3 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 008415171C103S3 | 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 (2)
- EUDAMED 378da45d-6425-45c4-85f4-c2bf2a85b484 61 fields · synced Jul 18, 2026
- EUDAMED 555bb972-afd7-41d7-afa1-530f0f5b77b8 61 fields · synced May 18, 2026