ECO Series Diagnostic Ultrasound Systems
FDA UDIEUDAMEDClass II (US FDA UDI)
Identity
- Trade Name
- CHISON EUDAMEDECO Series Diagnostic Ultrasound Systems FDA UDIXBit Series Digital Color Doppler Ultrasound System FDA UDI
- Generic Name
- Foetal Doppler system probe FDA UDIGeneral-purpose ultrasound imaging system FDA UDI
- Device Name
- Diqital Color Doppler Ultrasound Svstem EUDAMED
- Model / Reference
- XBit 70 EUDAMEDFDA UDIXBit 90 EUDAMEDECO 1 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06945121413237 EUDAMEDFDA UDI06945121407311 FDA UDI
- Basic UDI-DI
- 69451214XBitYH EUDAMED
- FDA Product Code
- IYN FDA UDIIYO FDA UDI
- EMDN Code
- Z11040104 MULTIDISCIPLINARY ULTRASOUND SCANNERS (INTERNAL AND CARDIOLOGY, ETC.) EUDAMED
- GMDN Term
- Foetal Doppler system probe FDA UDIGeneral-purpose ultrasound imaging system FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.1550 FDA UDI892.1560 FDA UDI
- Market of Registration
- Italy EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
Yes
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
Category: Foetal Doppler system probe
ECO Series Diagnostic Ultrasound Systems by CHISON Medical Technologies Co., Ltd. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED
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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 SeriesTrolley — 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 (2 countries)
Regulatory Authorizations
MDR
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
- CHISON Medical Technologies Co., Ltd.
Sources (3)
- FDA UDI d2132ace-f318-4b47-b4a6-07e143c2a19d 33 fields · synced Jul 23, 2026
- FDA UDI 45a94e27-3036-4aa3-9e56-95eafa9819ce 33 fields · synced May 30, 2026
- EUDAMED 524a6616-9c71-4134-b421-163c9c705367 61 fields · synced Jul 23, 2026