Identity
- Trade Name
- UMT-160 Mobile Trolley FDA UDI
- Generic Name
- Electromechanical device/system transport trolley FDA UDI
- Model / Reference
- 045-000740-01 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936415911263 FDA UDI
- 510(k) Number
- K182603 FDA UDI
- FDA Product Code
- IYN FDA UDI
- GMDN Term
- Electromechanical device/system transport trolley 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: Electromechanical device/system transport trolley
UMT-160 Mobile Trolley by Shenzhen Mindray Bio-Medical Electronics Co. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Cleared under the same submission
K182603 also covers:
- 35C50P Ultrasonic Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- 4D Module Kit — Shenzhen Mindray Bio-Medical Electronics Co.
- 75L38P Ultrasonic Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- D6-2P Ultrasonic Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- ECG Module(AHA lead/FDA/Z6) — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-006 Needle-guided Bracket/STEEL — Shenzhen Mindray Bio-Medical Electronics Co.
- NGB-016 Needle-guided Bracket — Shenzhen Mindray Bio-Medical Electronics Co.
- P7-3P Ultrasonic Probe(FDA) — Shenzhen Mindray Bio-Medical Electronics Co.
- UMT-150 Mobile Trolley — Shenzhen Mindray Bio-Medical Electronics Co.
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
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 |
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Manufacturer
- Manufacturer
- Shenzhen Mindray Bio-Medical Electronics Co.
Sources (2)
- FDA UDI c5193cee-e9ce-4d2d-a6f2-1f5210d06446 34 fields · synced Jun 7, 2026
- EUDAMED 1 fields · synced May 22, 2026