FDA Device Establishments · JSON-LD · Markdown

SHANDON DIAGNOSTICS LIMITED

FEI 3003584784 · Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device · Status: Active

FEI Number3003584784
Owner / OperatorEpredia Holdings Ltd. (#10062642)
AddressTUDOR ROAD, MANOR PARK, RUNCORN Cheshire East, WA7 1TA, GB
Mandatory US Agentnew erie scientific llc
Registration expiry2026
Initial importer flagN
Registered products3
Product codes (top 20)PZZ, PSY, QKQ
Regulation § (21 CFR)864.3700
Proprietary namesEpredia E1000 Dx Digital Pathology Solution

External sources

Source: openFDA. Public-domain (CC0).