EV3-10X
by Alpinion Medical Systems Co., Ltd.
EV3-10X is a Class II device made by Alpinion Medical Systems Co., Ltd., listed in FDA GUDID since 23 Sep 2016 (UDI-DI 08800013513090), registry data as of 21 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08800013513090 | Date23 Sep 2016 | StatusListed |
Official records
- AccessGUDID record 08800013513090
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Generic name
- Rectal/vaginal ultrasound imaging transducer
- Model / reference
- EV3-10X
- Primary DI / UDI-DI
- 08800013513090
- FDA product code
- ITX, IYO, IYN
- GMDN term
- Rectal/vaginal ultrasound imaging transducer
- Device class
- Class II
- Regulation number
- 892.1570, 892.1560, 892.1550
- GUDID distribution status
- In Commercial Distribution
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