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EUROPLUS Granulocyte Mosaic 25 EUROPattern

Model FC 1201-2005-25 · EUROIMMUN Medizinische Labordiagnostika AG · DI 04049016108856

MOB — Test System, Antineutrophil Cytoplasmic Antibodies (Anca) · Class II · 21 CFR 866.5660

MVJ — Devices, Measure, Antibodies To Glomerular Basement Membrane (Gbm) · Class II · 21 CFR 866.5660

PIV — Automated Indirect Immunofluorescence Microscope And Software-Assisted System For Clinical Use · Class II · 21 CFR 866.4750

UDILibrary device dossier · generated 2026-09-15 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

01112025-06: 0 reports for this device; peer average 1/device06
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2025-0601
This device (reports/month)Average device in MOB, MVJ, PIV (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — EUROIMMUN Medizinische Labordiagnostika AG

  • NAI 2015-06-11 EUROIMMUN Medizinische Labordiagnostika AG · 0 citations
  • NAI 2015-06-11 EUROIMMUN Medizinische Labordiagnostika AG · 0 citations