Medical device registrations across 25 markets: coverage gaps, 510(k) predicates, classification
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https://meridiantrace.com/v1/mcp12 tools · 422mssearch_manufacturerResolve a company name to a Meridian manufacturer entity — the entry point for every other tool. Names are unified across spelling variants and scripts, so "Medtronic", "Медтроник" and "美敦力" reach the same entity, and subsidiaries resolve to the parent that owns them. Returns up to 5 candidates wit…Resolve a company name to a Meridian manufacturer entity — the entry point for every other tool. Names are unified across spelling variants and scripts, so "Medtronic", "Медтроник" and "美敦力" reach the same entity, and subsidiaries resolve to the parent that owns them. Returns up to 5 candidates wit…
| Parameter | Type | Description |
|---|---|---|
| name* | string | Company name to search for |
| country | string | Optional ISO2 or full country name to narrow results (e.g. "SG" or "Singapore") |
get_registrationsEvery individual registration held by a manufacturer — product name, registration number, status, dates, risk class and source registry — filterable by market and status. Each row also carries an `enrichment` block Meridian derived: device class as a RANK on that market's own scale ("3 of 4") rathe…Every individual registration held by a manufacturer — product name, registration number, status, dates, risk class and source registry — filterable by market and status. Each row also carries an `enrichment` block Meridian derived: device class as a RANK on that market's own scale ("3 of 4") rathe…
| Parameter | Type | Description |
|---|---|---|
| manufacturer_id* | string | — |
| market | string | Filter to a single market — ISO2 code (e.g. "SG") or full name (e.g. "Singapore") |
| status | string | Filter by lifecycle state: "active", "expired", "cancelled" or "pending". These are applied as RULES, not string matching — a market that publishes no status (… |
| page | number | Page number (default 1) |
| limit | number | Results per page (default 50, max 200) |
get_registrationOne registration, complete. Everything get_registrations returns for that row, plus the registry's own market-specific fields under `registryFields` — Korea's renewal window, Australia's intended purpose, Saudi's authorisation pathway, the EUDAMED device attributes (implantable, sterile, reusable,…One registration, complete. Everything get_registrations returns for that row, plus the registry's own market-specific fields under `registryFields` — Korea's renewal window, Australia's intended purpose, Saudi's authorisation pathway, the EUDAMED device attributes (implantable, sterile, reusable,…
| Parameter | Type | Description |
|---|---|---|
| registration_id* | string | Registration id from get_registrations, find_similar_devices or get_recent_registrations. |
get_license_holdersThe local entities that actually hold a foreign manufacturer's registrations — the importers, distributors and regulatory consultants named on the licence in each market. In Malaysia, Indonesia and Thailand the registry names this local party rather than the OEM, so this is the only way to see who…The local entities that actually hold a foreign manufacturer's registrations — the importers, distributors and regulatory consultants named on the licence in each market. In Malaysia, Indonesia and Thailand the registry names this local party rather than the OEM, so this is the only way to see who…
| Parameter | Type | Description |
|---|---|---|
| manufacturer_id* | string | — |
find_distributorsRUNS WITHOUT AN API KEY (anonymous callers see the top 3 per market and are told how many more matched). WHO COULD SELL A DEVICE IN A MARKET — the question a company entering a market actually has. Give it a market and, optionally, a device type or clinical area; it returns the local distributors a…RUNS WITHOUT AN API KEY (anonymous callers see the top 3 per market and are told how many more matched). WHO COULD SELL A DEVICE IN A MARKET — the question a company entering a market actually has. Give it a market and, optionally, a device type or clinical area; it returns the local distributors a…
| Parameter | Type | Description |
|---|---|---|
| market* | string | ISO2 code or market name, e.g. "TH" or "Thailand". One market per call. |
| device_type | string | Optional clinical area or device category in plain words, e.g. "orthopaedic implants", "in vitro diagnostics", "cardiology". Partial matches count. Omit it to… |
| limit | number | 1-25 (default 10). Capped to 3 without a paid key. |
get_market_coverageTHE cross-market question, answered in one call: every market where this manufacturer IS registered and every market where they are NOT. Returns per-market registration and active-registration counts and the source registries, plus the markets absent from their footprint — which is the gap a market…THE cross-market question, answered in one call: every market where this manufacturer IS registered and every market where they are NOT. Returns per-market registration and active-registration counts and the source registries, plus the markets absent from their footprint — which is the gap a market…
| Parameter | Type | Description |
|---|---|---|
| manufacturer_id | string | The Meridian Trace manufacturer _id, from search_manufacturer |
| name | string | Company name, as an alternative to manufacturer_id. Resolves the same way search_manufacturer does and uses the best match. |
| ticker | string | Listed ticker (e.g. "MDT"), as an alternative to manufacturer_id or name. Covers US-listed registrants; many large device makers are private or listed only out… |
get_registration_timelineNew registrations per year for a manufacturer, split by market — the pace at which a company is entering markets and launching products, years before it appears in reported revenue. Built from each registry's own approval date, so it reaches back as far as the registry publishes (56 years for the U…New registrations per year for a manufacturer, split by market — the pace at which a company is entering markets and launching products, years before it appears in reported revenue. Built from each registry's own approval date, so it reaches back as far as the registry publishes (56 years for the U…
| Parameter | Type | Description |
|---|---|---|
| manufacturer_id | string | From search_manufacturer |
| name | string | Company name, as an alternative to manufacturer_id |
| ticker | string | Listed ticker, e.g. "SYK" (US-listed coverage) |
| from_year | number | First year to include (default: 10 years ago) |
| to_year | number | Last year to include (default: current year) |
| market | string | Restrict to one market (ISO2 or full name) |
find_predicatesUS 510(k) predicate lineage, from the predicates actually cited in each clearance's own summary document — not a similarity guess. 64,567 clearances, 1992-2026. By k_number: what that device cited, AND which later devices cited IT as a predicate — the reverse direction shows whose clearances rest o…US 510(k) predicate lineage, from the predicates actually cited in each clearance's own summary document — not a similarity guess. 64,567 clearances, 1992-2026. By k_number: what that device cited, AND which later devices cited IT as a predicate — the reverse direction shows whose clearances rest o…
| Parameter | Type | Description |
|---|---|---|
| k_number | string | A 510(k) number, e.g. "K191275" |
| product_code | string | An FDA product code, e.g. "LIT" |
| limit | number | Max rows per list (default 20, max 50) |
classify_deviceRUNS WITHOUT AN API KEY (anonymous callers see the top 3 FDA product codes and the full per-market risk table — a free key unlocks the rest). Classification view of a device type: the GMDN hierarchy it sits in, the FDA product codes it maps to with how many devices carry each, and — the part not pu…RUNS WITHOUT AN API KEY (anonymous callers see the top 3 FDA product codes and the full per-market risk table — a free key unlocks the rest). Classification view of a device type: the GMDN hierarchy it sits in, the FDA product codes it maps to with how many devices carry each, and — the part not pu…
| Parameter | Type | Description |
|---|---|---|
| gmdn_code | string | GMDN code, e.g. "44727" |
| device_type | string | A device name in plain words ("insulin pump", "orthopaedic plate") or a GMDN term. US and British spellings both resolve. Name the device, not the brand or the… |
| fda_product_code | string | FDA product code, e.g. "DZE" |
find_similar_devicesCompeting and comparable devices for a registration, matched on resolved device type (GMDN) rather than product-name text, and spread across markets so the answer is not all one country. Excludes the same manufacturer, so what comes back is the competitive set. Each result carries a match band. Use…Competing and comparable devices for a registration, matched on resolved device type (GMDN) rather than product-name text, and spread across markets so the answer is not all one country. Excludes the same manufacturer, so what comes back is the competitive set. Each result carries a match band. Use…
| Parameter | Type | Description |
|---|---|---|
| registration_id | string | The _id of a registration, from get_registrations |
| device_name | string | A product name, as an alternative to registration_id — the closest registration is used as the reference device |
| market | string | With device_name, restrict the reference lookup to one market (ISO2) |
| limit | number | Max results (default 15) |
get_recent_registrationsRegistrations newly added to Meridian in the last N days, optionally filtered by market, risk class or device type — the competitor-monitoring feed. Ordered by when we first saw the record, so it surfaces market entries as they appear rather than by approval date. US PMA supplements are excluded: t…Registrations newly added to Meridian in the last N days, optionally filtered by market, risk class or device type — the competitor-monitoring feed. Ordered by when we first saw the record, so it surfaces market entries as they appear rather than by approval date. US PMA supplements are excluded: t…
| Parameter | Type | Description |
|---|---|---|
| days | number | Look-back window, 1-180 (default 30) |
| markets | array | ISO2 codes, e.g. ["TH","ID"] |
| risk_level | string | Low | Medium | High |
| device_type | string | Resolved GMDN device type |
| limit | number | Max results (default 50, max 100) |
get_coverageRUNS WITHOUT AN API KEY — call it right now to check us before signing up for anything. What Meridian Trace actually holds: every source registry, the market it covers, how many registrations are on file from it, and when it was last crawled. Call this to verify coverage and freshness for yourself…RUNS WITHOUT AN API KEY — call it right now to check us before signing up for anything. What Meridian Trace actually holds: every source registry, the market it covers, how many registrations are on file from it, and when it was last crawled. Call this to verify coverage and freshness for yourself…
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Medical device registrations across 25 markets: coverage gaps, 510(k) predicates, classification
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