SansaTM 1000-01
SansaTM 1000-01 is a Class II device made by Huxley Medical, listed in FDA GUDID since 21 Oct 2024 (UDI-DI G2331000010), registry data as of 23 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 | NumberG2331000010 | Date21 Oct 2024 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- SansaTM
- Generic name
- Wearable multiple physiological parameter recorder, reusable
- Model / reference
- 1000-01
- Primary DI / UDI-DI
- G2331000010
- FDA product code
- MNR, BZQ, MWJ
- GMDN term
- Wearable multiple physiological parameter recorder, reusable
- Device class
- Class II
- Regulation number
- 868.2375, 870.2800
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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