FEI 3015134004
Current Health Ltd
The Stamp Office, Level 3, Edinburgh Edinburgh, City of, GB
MDR events6All time
Recalls0All time
Registered products6
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
6 product codes
Recent MDR events
6 on file
- WEARABLE NASAL CANNUALJun 1, 2026DeathMW5188818
- CURRENT HEALTH MONITORING SYSTEM GEN 2 (G2)Sep 9, 2024DeathMW5159361
- CURRENT_HEALTH_WEARABLE_V2Apr 19, 2024DeathMW5154019
- CURRENT_HEALTH_HOMEHUBApr 19, 2024DeathMW5154020
- CURRENT_HEALTH_TABLETApr 19, 2024DeathMW5154022
- CURRENT HEALTH LTD SECOND GENERATIONDec 24, 2020InjuryMW5098542
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3015134004.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Feb 15, 2024
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Feb 15, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.90(a)Feb 15, 2024
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.100(b)Feb 15, 2024
Documentation
- 21 CFR 820.198(e)Feb 15, 2024
Records of complaint investigation - UDI
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.