Identity
- Trade Name
- PEM-3 Probe Extend(MT2) FDA UDI
- Generic Name
- General-purpose ultrasound imaging system FDA UDI
- Model / Reference
- 115-070437-00 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936415982539 FDA UDI
- 510(k) Number
- K200001 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
PEM-3 Probe Extend(MT2) 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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- HS50 / HS60 Diagnostic Ultrasound System — SAMSUNG MEDISON CO., LTD · Class II
- MEDISONO — Medisono, LLC · Class II
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Cleared under the same submission
K200001 also covers:
- ECG Module — Shenzhen Mindray Bio-Medical Electronics Co.
- L13-3Ns Ultrasonic Transducer (FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- L13-3s Ultrasonic Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- MT2 CART(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-043 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-044 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
- SC5-1Ns Ultrasonic Transducer (FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- SP5-1Ns Ultrasonic Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- V11-3Hs Ultrasonic Probe(FDA) — 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 10072516-f5ab-40ff-9ad2-722e68ef039a 33 fields · synced Jun 7, 2026