Identity
- Trade Name
- M7 Ultrasound system FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Model / Reference
- M7 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06944904028781 FDA UDI
- FDA Product Code
- IYN FDA UDI
- GMDN Term
- General-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1550 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: General-purpose ultrasound imaging system
M7 Ultrasound system by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131690 also covers:
- 4CD4s Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- Display Module(M7, International, Alone) — Shenzhen Mindray Bio-Medical Electronics Co.
- ECG Module(ANA lead/FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- IO Extend Module(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- L14-6s Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- L7-3s Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- M7 PEM(FDA, PEM-21, For UMT-200) — Shenzhen Mindray Bio-Medical Electronics Co.
- M7 Probe Extend Module(FDA, Alone) — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-010 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-018 Needle-guided Bracket/VET — Shenzhen Mindray Bio-Medical Electronics Co.
- P12-4s Ultrasonic Transducer(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- Power(No power cord, International) — 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 a59bf4c8-dcaa-48e5-a6ad-948da5587449 34 fields · synced May 30, 2026