Identity
- Trade Name
- L10-3s Ultrasonic Probe(SMS) FDA UDI
- Generic Name
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
- Model / Reference
- 120-005507-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904096995 FDA UDI
- FDA Product Code
- ITX FDA UDI
- GMDN Term
- Extracorporeal ultrasound imaging transducer, hand-held FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1570 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
MR Unsafe FDA UDI
Category: Extracorporeal ultrasound imaging transducer, hand-held
L10-3s Ultrasonic Probe(SMS) by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- 4C1 Transducer — SIEMENS MEDICAL SOLUTIONS USA, INC. · Class II
- UST-5419 — FUJIFILM Corporation · Class II
- P4-12 — SAMSUNG MEDISON CO., LTD · Class II
Cleared under the same submission
K171034 also covers:
- C11-3s Ultrasonic Transducer(SMS) — Shenzhen Mindray Bio-Medical Electronics Co.
- C5-1s Ultrasonic Transducer(SMS) — Shenzhen Mindray Bio-Medical Electronics Co.
- CW2s Ultrasonic Transducer(SMS) — Shenzhen Mindray Bio-Medical Electronics Co.
- CW5s Ultrasonic Transducer(SMS) — Shenzhen Mindray Bio-Medical Electronics Co.
- DC-IN CABLE — Shenzhen Mindray Bio-Medical Electronics Co.
- Diagnostic Ultrasound system — Shenzhen Mindray Bio-Medical Electronics Co.
- L12-4s Ultrasonic Transducer(SMS) — Shenzhen Mindray Bio-Medical Electronics Co.
- L14-6Ns Ultrasonic Transducer(SMS) — Shenzhen Mindray Bio-Medical Electronics Co.
- L16-4Hs Ultrasonic Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- L16-4Hs Ultrasonic Probe(SMS) — Shenzhen Mindray Bio-Medical Electronics Co.
- L20-5s Ultrasonic Probe(SMS) — Shenzhen Mindray Bio-Medical Electronics Co.
- M8 Elite Portable Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co.
K172970 also covers:
- 1D Bar Code Scanners(USB) Kit — Shenzhen Mindray Bio-Medical Electronics Co.
- 2-pedal Footswitch，USB Plug Kit — Shenzhen Mindray Bio-Medical Electronics Co.
- 3-Lead, ECG, Univ, Pinch, 36", AAMI Kit — Shenzhen Mindray Bio-Medical Electronics Co.
- 3/5 ECG Lead (10') Kit — Shenzhen Mindray Bio-Medical Electronics Co.
- 6C2s Ultrasonic Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- B/W video printer(FDA) Kit — Shenzhen Mindray Bio-Medical Electronics Co.
- C11-3s Ultrasonic Transducer(SMS) — Shenzhen Mindray Bio-Medical Electronics Co.
- C5-1s Ultrasonic Transducer(SMS) — Shenzhen Mindray Bio-Medical Electronics Co.
- CW2s Ultrasonic Transducer(SMS) — Shenzhen Mindray Bio-Medical Electronics Co.
- CW5s Ultrasonic Transducer(SMS) — Shenzhen Mindray Bio-Medical Electronics Co.
- Carts Lithium-ion Battery Kit — Shenzhen Mindray Bio-Medical Electronics Co.
- DC-IN CABLE（MIC）Kit — Shenzhen Mindray Bio-Medical Electronics Co.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (1)
- FDA UDI 5e2bb6e1-2a22-4348-afbe-fad85797fcd6 33 fields · synced May 30, 2026