FDA Device Establishments · JSON-LD · Markdown

SIRIUS MEDICAL SYSTEMS B.V.

FEI 3020733550 · Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198 · Status: Active

FEI Number3020733550
Owner / OperatorSirius Medical Systems B.V. (#10082996)
AddressHigh Tech Campus 41, Eindhoven Noord-Brabant, 5656AE, NL
Registration expiry2026
Initial importer flagN
Registered products2
Product codes (top 20)NEU, PBY
Regulation § (21 CFR)878.4300
Proprietary namesSirius Pintuition Seed 7cm; Sirius Pintuition Test Kit; Sirius Pintuition Base Unit; Sirius Pintuition Slim Probe; Sirius Pintuition Slim Test Kit; Sirius Pintuition Seed 12cm; Sirius Pintuition Probe

External sources

Source: openFDA. Public-domain (CC0).