10EV3 transducer
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- 10EV3 transducer EUDAMEDFDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Device Name
- MDR_07_IIA_IQH_BTS LB A_ACDV_10EV3_11502928 EUDAMED
- Model / Reference
- 11502928 EUDAMEDFDA UDIMDR_07_IIA_IQH_BTS LB A_ACDV_10EV3_11502928 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 04056869266268 EUDAMEDFDA UDI
- Basic UDI-DI
- 0405686902448VZ EUDAMED
- 510(k) Number
- K221500 FDA UDI
- FDA Product Code
- ITX FDA UDI
- EMDN Code
- Z1104020201 ENDOCAVITARY ULTRASOUND PROBES, TWO–DIMENSIONAL 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
- Germany 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
No
Category: Extracorporeal ultrasound imaging transducer, hand-held
10EV3 transducer by Siemens Medical Solutions Usa, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Extracorporeal ultrasound imaging transducer, hand-held.
- Biim Android App, P1.3 — Biim Ultrasound AS · Class II
- Battery Charger AU, Biim Ultrasound — Biim Ultrasound AS · Class II
- SonoScape — SONOSCAPE MEDICAL CORP. · Class II
- UST-5419 — FUJIFILM Corporation · Class II
- P4-12 — SAMSUNG MEDISON CO., LTD · Class II
- C613 — SONOSCAPE MEDICAL CORP. · Class IIa
- UST-5296 — FUJIFILM Corporation · Class II
- 7L4A Ultrasonic Probe(V2.0/FDA) — Shenzhen Mindray Bio-Medical Electronics Co. · Class II
Cleared under the same submission
K221500 also covers:
Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Siemens Medical Solutions Usa, Inc.
Sources (2)
- FDA UDI 0512f6d9-e970-4367-8a9f-03350d3acfdf 35 fields · synced Oct 7, 2026
- EUDAMED 614e44f5-df72-4417-9f31-02930c31f34f 61 fields · synced Oct 7, 2026