K250459

Substantially Equivalent

DMRX 100ml Empty Container Solution; DMRX 250ml Empty Container Solution; DMRX 500ml Empty Container Solution; DMRX 1000ml Empty Container Solution

Applicant: Technoflex Sas.
Product code: KPE
Advisory panel: General Hospital
Date received: 2025-02-18
Decision date: 2025-04-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bidart, FR

Download summary PDF View on FDA.gov ↗

Adverse events under product code KPE

product code KPE

Malfunction: 1,000
Other: 1
Total: 1,001

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.