Identity
- Trade Name
- ECO SeriesTrolley FDA UDI
- Generic Name
- Utility trolley FDA UDI
- Model / Reference
- TR-9000 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945121409698 FDA UDI
- 510(k) Number
- K131305 FDA UDI
- FDA Product Code
- IYO FDA UDIIYN FDA UDI
- GMDN Term
- Utility trolley FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 892.1560 FDA UDI892.1550 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
No
FDA UDI
Category: Utility trolley
ECO SeriesTrolley by CHISON Medical Technologies Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K131305 also covers:
- Convex probe — CHISON Medical Technologies Co., Ltd.
- Convex probe — CHISON Medical Technologies Co., Ltd.
- ECO Series Diagnostic Ultrasound Systems — CHISON Medical Technologies Co., Ltd.
- ECO Series Diagnostic Ultrasound Systems — CHISON Medical Technologies Co., Ltd.
- ECO Series Diagnostic Ultrasound Systems — CHISON Medical Technologies Co., Ltd.
- ECO Series Diagnostic Ultrasound Systems — CHISON Medical Technologies Co., Ltd.
- Linear probe — CHISON Medical Technologies Co., Ltd.
- Linear probe — CHISON Medical Technologies Co., Ltd.
- Linear probe — CHISON Medical Technologies Co., Ltd.
- Micro convex probe — CHISON Medical Technologies Co., Ltd.
- Phased array probe — CHISON Medical Technologies Co., Ltd.
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
- CHISON Medical Technologies Co., Ltd.
Sources (1)
- FDA UDI cfaa3155-e41f-4dd5-9a37-d307d3959351 33 fields · synced Jun 1, 2026