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Health Wealth Safe

Mio Labs Inc. · Model HH-XIII-T · UDI-DI 00850042929360

QRLQRK
10
510(k) clearances
238
Adverse events
1
Recalls
87
Facilities

Description

Lancing Device

Recalls

DateFirmReason
2025-07-25Home Health US, IncorporatedDue to incorrect/lack of Unique Device Identifier (UDI) codes.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.