Identity
- Trade Name
- TEX10S Diagnostic Ultrasound System FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Model / Reference
- TEX10S FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06903053003964 FDA UDI
- 510(k) Number
- K241201 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
No
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
TEX10S Diagnostic 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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Also classified as General-purpose ultrasound imaging system.
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Cleared under the same submission
K241201 also covers:
- Anesus TEX20 Pro Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co.
- Eagus TEX10T Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co.
- Eagus TEX11T — Shenzhen Mindray Bio-Medical Electronics Co.
- Eagus TEX20 Diagnostic Ultrasound System — Shenzhen Mindray Bio-Medical Electronics Co.
- TEX10T Diagnostic Ultrasound System — 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 07374771-b2ed-4fd2-a2b8-c411089fcd13 33 fields · synced May 30, 2026