com.meridiantrace/medical-device-registrations

Tools

• classify_device

  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 published anywhere — how the SAME device type is actually risk-classed market by market, with the sample size behind each. Risk class is not portable: a device type can be modal High in Canada and modal Medium in the EU and Singapore, which changes submission route, evidence burden and timeline. Accepts a GMDN code, a GMDN term (partial is fine), or an FDA product code. Observed practice, not a regulatory determination.

  shallow
• find_predicates

  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 on your device and how contested a space is. By product_code: the predicates that code leans on most, ranked by how often they are cited, plus recent clearances. Use when choosing a predicate, assessing substantial equivalence, or mapping who is clearing devices in a classification.

  shallow
• find_similar_devices

  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 for competitive landscape, classification precedent in other markets, and finding how the same device type is described elsewhere. Get a registration_id from get_registrations.

  shallow
• get_coverage

  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 before relying on other tools, or to answer "do you cover market X, and how current is it?". No arguments.

  shallow
• get_license_holders

  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 controls market access for a product, who a competitor is partnered with, and whether a manufacturer uses one partner or many.

  shallow
• get_market_coverage

  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-access team is usually looking for ("registered in Indonesia and Thailand, missing in the Philippines"). Prefer this over get_registrations when the question is about market presence rather than individual products. A `marketAccess` block may also appear. It is NOT a registration and is excluded from marketCount and every count in this response: it reports market access held on another basis — currently PMDA foreign manufacturer accreditation, which licenses a manufacturing SITE to make devices for Japan, precedes product approval and outlives individual products. When it is present alongside Japan in `absent`, both are true and the distinction matters: the company can supply the market but has no Japanese product approval visible to us. Do not describe that as being registered in Japan, and do not add it to a market count.

  shallow
• get_recent_registrations

  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: they are labeling and site changes against an existing approval, not new registrations. Filtering by market is much faster — unfiltered across all markets can take up to 15 seconds, a market or two returns in about a second.

  shallow
• get_registration_timeline

  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 US). Every market carries a historyQuality flag: complete_archive and retains_lapsed series are safe to trend, current_state_only markets publish only today's position and undercount anything since withdrawn. Use for entry velocity, launch cadence, and comparing two competitors' expansion over time.

  shallow
• get_registrations

  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 carries a `provenance` block naming any field Meridian derived (inferred, classified, translated) with a confidence band where one applies; every field NOT listed there is the registry's own value, unmodified. Use that to lean on verbatim fields and hedge on derived ones. Use get_market_coverage instead when the question is which markets a company is in.

  shallow
• search_manufacturer

  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 with a confidence rating and their market footprint. A plain web search cannot do this: a manufacturer's Asian registrations are filed under local-script names that never appear alongside the English one.

  shallow

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