C35x/8-3 Mhz
EUDAMEDFDA UDIClass IIa (EU MDR)
Identity
- Trade Name
- C35x/8-3 Mhz EUDAMEDFDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- TRANSDUCER, C35X/8-3 MHZ EUDAMED
- Model / Reference
- TRANSDUCER, C35X/8-3 MHZ EUDAMEDP30364-02 EUDAMEDP21981-20 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- P21981 FDA UDI
- Primary DI / UDI-DI
- 00841517111144 EUDAMED00841517104986 EUDAMEDFDA UDI
- Basic UDI-DI
- 08415171C35XCF EUDAMED
- 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
- Denmark 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
C35x/8-3 Mhz by Fujifilm Sonosite, Inc. — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 08415171C35XCF | 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 (3)
- EUDAMED 5623ced4-1a5f-486f-9f0e-fcc7eb221f8c 61 fields · synced Jul 30, 2026
- EUDAMED d7a79bf0-ca55-4cbd-a9e2-44df0ac27ecf 61 fields · synced May 18, 2026
- FDA UDI e2ec6e86-c859-4cb9-b6b7-53c53d3d4e58 36 fields · synced May 30, 2026