Everion+ System EVRPLUS-G
by Biofourmis Singapore Pte., Ltd.
Everion+ System EVRPLUS-G is a Class II device made by Biofourmis Singapore Pte., Ltd., cleared under FDA 510(k) K213863 on 23 Feb 2023 and listed in FDA GUDID since 22 Mar 2023 (UDI-DI 08885018690007), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08885018690007 | Date22 Mar 2023 | StatusListed |
| United States | FDA 510(k)SESE | NumberK213863 | Date23 Feb 2023 | StatusActive |
Official records
- AccessGUDID record 08885018690007
- FDA 510(k) database K213863
Across registries
- FDA 510(k) K213863 decided 23 Feb 2023 Active
- FDA GUDID UDI-DI 08885018690007 listed 22 Mar 2023 Listed
Timeline
- Cleared FDA 510(k) K213863
- Listed FDA GUDID 08885018690007
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Everion+ System
- Generic name
- Wearable multiple physiological parameter recorder, reusable
- Model / reference
- EVRPLUS-G
- Primary DI / UDI-DI
- 08885018690007
- 510(k) Number
- FDA product code
- MWI, MSX
- GMDN term
- Wearable multiple physiological parameter recorder, reusable
- Device class
- Class II
- Regulation number
- 870.2300
- GUDID distribution status
- In Commercial Distribution
- MRI safety
- MR Unsafe
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