Identity
- Trade Name
- C 1-8 EUDAMEDFDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- Convex / Radius > 40 Low frequency EUDAMEDC 1-8 EUDAMED
- Model / Reference
- 120000013 EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08056304452917 EUDAMEDFDA UDI
- Basic UDI-DI
- 805630445ESA.PR0000001.SK EUDAMEDB-08056304452917 EUDAMED
- 510(k) Number
- K173291 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z110402010201 CURVILINEAR TRANSCUTANEOUS TWO–DIMENSIONAL ULTRASOUND PROBES (CONVEX–ARRAY) 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
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Extracorporeal ultrasound imaging transducer, hand-held
C 1-8 by Esaote S.p.A. — Class IIa — MDD, MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 805630445ESA.PR0000001.SK | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 805630445ESA.PR0000001.SK | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Esaote S.p.A.
- EUDAMED SRN
- IT-MF-000019024
Sources (3)
- EUDAMED aab944be-2235-4c87-a706-1168fde003d4 61 fields · synced Aug 1, 2026
- EUDAMED 4ae0f0dd-9b53-4801-8ff1-5261fc8a44d4 61 fields · synced May 19, 2026
- FDA UDI b15da8ed-2bb0-410b-baab-92a2029b7d7a 33 fields · synced May 30, 2026