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medxpert-reg-hub · MCP Server

Read-only medical device regulatory MCP server. Tools (all read-only):

  • udi_lookup — NMPA UDI queries (main DI / product name / registration no.)
  • fda_510k_lookup — FDA 510(k) queries (K-number / company / product)
  • pma_lookup — FDA PMA queries (PMA number / company / product)
  • class_lookup — FDA product classification queries (product code / name)
  • hub_search — keyword search across the 20-hub regulatory knowledge base (CN/US/EU/JP)

Install & run

pip install medxpert-reg-hub
medxpert-mcp        # stdio MCP server

Data (MEDXPERT_DB / MEDXPERT_REFS)

The PyPI wheel is metadata-light by design (the full dataset is ~600M+ rows across SQLite). Point the server at your data:

export MEDXPERT_DB=/path/to/medxpert_device.sqlite
export MEDXPERT_REFS=/path/to/skills/references
medxpert-mcp

The reference data bundle is published in the GitHub repo stevenzhao07/medxpert-reg-hub (docs/ and skills/references/), so you can clone it and set the env vars, or use your own RA knowledge base.

License: MIT © 2026 MedXpert

Metadata

Release files for medxpert-reg-hub 2.0.1

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