Medical device registration data from 36 national registries, callable over the Model Context Protocol. Free developer key, no card.
Meridian Trace speaks the Model Context Protocol over HTTP. Point any MCP-capable client at the endpoint and authenticate with an API key. Get one at meridiantrace.com/api — the Developer tier is free, needs no card, and includes 100 calls a month.
{
"mcpServers": {
"meridian-trace-medical-devices": {
"url": "https://meridiantrace.com/v1/mcp",
"headers": { "X-API-Key": "mt_your_key_here" }
}
}
}The transport is JSON-RPC 2.0 over HTTP POST. Call initialize for server instructions, then tools/list. Agents can also read /llms.txt.
What is easy: the US. openFDA is free, keyless and well-documented. If you only need US 510(k), PMA and classification data, build on it directly — you do not need us, and we would rather tell you that than sell you a wrapper. It is about 8% of what we hold.
What is not: the other 92% — 29 non-US markets holding the bulk of our 1.97M device registrations, none with an openFDA equivalent. Assembling it means reconciling thirty separate publication conventions across several non-Latin scripts, and then the real work: resolving one company across 30 naming conventions so that "which markets is this company missing" is answerable at all.
What you cannot build at any price: cross-registry facts. Of 1,017 device types with a settled risk classification in 3+ markets (≥20 records, ≥90% within-market agreement), 43% are classed differently between markets — a bone fixation screw is Medium in the EU (96% agreement, 8,433 records) and High in South Korea (98%, 187). That is in no source, because no source has more than one jurisdiction. It exists only once the records are joined.
Every number above is checkable with a free key, and get_coverage and
classify_device run without one — including the crawl date of every
registry, so you can see what is fresh before you trust any of it.
Most of this data is not on the open web in usable form, and the parts that are will mislead you.
21 of our 30 markets publish no bulk data at all. India, Brazil, Japan, Korea, Taiwan, China, Indonesia, Russia, Thailand, Vietnam, Saudi Arabia, Malaysia, Colombia, the Philippines and Israel are reachable only by scraping a registry, several of them local-language only. The US, EU, Canada and Australia have open bulk sources; the other 1.25 million records do not.
Company names do not match across markets. The same manufacturer appears as "Medtronic", "Медтроник" and "美敦力" depending on the registry. Meridian unifies them, and rolls subsidiaries up to the parent that owns them. A web search for a manufacturer misses its Asian registrations entirely, and — worse — returns nothing rather than an error, so the answer looks complete.
In Malaysia, Indonesia and Thailand the registry names the local licence holder, not the manufacturer. Read those registries literally and you will attribute a product to its distributor. Meridian infers the actual OEM on 94,229 records and marks the inference.
An example of what that produces: 78% of device types registered in four or more markets carry a different risk class in at least one — a comparison no single registry publishes, because it is not any one registry's fact.
Two tools answer without any authentication, so you can satisfy yourself that the data is
real and current before asking anyone for a key: get_coverage returns all 36
registries with record counts and last crawl dates, and classify_device returns
the GMDN hierarchy, FDA product codes and observed risk class per market for any device type.
Everything that names a company needs a key.
curl -s https://meridiantrace.com/v1/mcp -H "content-type: application/json" \
-d '{"jsonrpc":"2.0","id":1,"method":"tools/call",
"params":{"name":"get_coverage","arguments":{}}}'| Tool | Answers |
|---|---|
search_manufacturer | Resolve a company name to an entity. The entry point for everything else. |
get_market_coverage | Every market a manufacturer is registered in, and every market they are not. Accepts a name or a ticker. |
get_registrations | Individual registrations, filterable by market and status. |
get_license_holders | The local importer or distributor holding a NAMED manufacturer’s registrations — starts from a company you can already name. |
find_distributors | The inverse, and the one to reach for when entering a market. Give it a market and a device type; it returns the local distributors and importers who hold registrations there, their clinical areas, and a sample of the lines they already carry. Strongest across Asia. No API key needed for the top 3 per market. |
find_predicates | US 510(k) predicate lineage — what a device cited, and which later devices cited it. Or, by product code, the predicates a classification leans on most. |
find_similar_devices | Competing devices of the same resolved device type, across markets and languages. |
classify_device | GMDN hierarchy, FDA product codes, and how the same device type is risk-classed market by market. |
get_registration_timeline | New registrations per year per market, with a history-quality flag per market. |
get_recent_registrations | Recently added registrations — the competitor-monitoring feed. |
get_coverage | Every source registry, record count and last crawl date. |
Coverage and freshness are the two things you cannot take on trust from a data provider, so both are queryable. get_coverage returns all 39 registries with a record count and a last-crawled date. Every other response carries a dataAsOf stamp. Registration records refresh on each registry crawl; manufacturer profiles rebuild weekly.
Where history is concerned, get_registration_timeline labels each market. The US and EU never remove a record, so those series are complete. Taiwan, Thailand, Canada and Japan retain lapsed registrations, so entries and exits are both real. The remaining markets publish only today's position — a trend built from them slopes upward purely because withdrawn products are missing from the past, and the flag says so rather than letting you find out later.
Not clinical or safety data. No adverse events, recalls or field safety notices. Not regulatory advice. Registration status is what a registry published as of the crawl date — while we work to keep it complete, source registries occasionally publish incomplete records, and anything informing a submission or filing decision should be verified against the official registry.
Developer access is free and self-serve: 100 calls a month, one key, no card. Paid plans raise call volume and key count. See meridiantrace.com/api for plans and to issue a key, or write to inquiries@meridiantrace.com.