BEUDAMED
    Research Assistant

    Regulatory research,
    shown working.

    Ask about EUDAMED and FDA data in plain language. The assistant runs the same tools as our API, shows every search it makes, and cites every record it uses.

    Start researching — free See example chats
    beudamed.com/assistant — live research chat
    Is Tristel registered as a manufacturer in EUDAMED, and do they have valid CE certificates?
    ✓ get_manufacturer_profile Tristel 312 ms
    ✓ verify_certificate CE 544967 148 ms
    Yes — Tristel Solutions Limited is registered as an Active manufacturer with SRN GB-MF-000010046. However, I did not find a currently valid CE certificate: CE 544967 expired 19 Apr 2024.
    Unedited, from a real research chat →
    What people use it for

    Four research jobs, one question each.

    Supplier verification
    Procurement & distributor teams vetting partners
    THEY ASK
    “Is this manufacturer registered in EUDAMED, and are their CE certificates still valid?”
    IT RETURNS
    Registration status, SRN, certificate validity — each linked to the record. SRN CE cert
    Predicate research
    The groundwork of every 510(k) submission
    THEY ASK
    “Which 510(k) predicates have been cited recently for pulse oximeters (product code DQA)?”
    IT RETURNS
    Recent clearances with their cited predicates and review times. K-numbers DQA
    Competitive analysis
    State-of-the-art and market landscape work
    THEY ASK
    “Which devices has this competitor registered in the EU, and with which notified bodies?”
    IT RETURNS
    Device portfolio, risk classes, and certifying notified bodies. Basic UDI-DI NB 2797
    Post-market data
    Vigilance groundwork for a PSUR
    THEY ASK
    “Pull adverse event trends and recent recalls for infusion pumps since 2024.”
    IT RETURNS
    MAUDE event trends, recalls, enforcements — export-ready. 25M+ MAUDE recalls
    Examples

    Real research chats, published as-is.

    510(k) Review Times and Product Code
    “How long do 510(k) reviews take for surgical masks, and which product code applies?”
    Read the full chat →
    Infusion Pump Adverse Events and Recalls since 2024
    “Pull adverse event trends and recent recalls for infusion pumps (product code FRN) since 2024.”
    Read the full chat →
    Laboratoire Huckert's EUDAMED Devices and Notified Body
    “What devices does Laboratoire Huckert's have registered in EUDAMED, and which notified body certified them?”
    Read the full chat →
    Recent 510(k) Predicates for DQA Pulse Oximeters
    “Which 510(k) predicates have been cited recently for pulse oximeters (product code DQA)?”
    Read the full chat →
    Tristel EUDAMED Registration and CE Certificate Status
    “Is Tristel registered as a manufacturer in EUDAMED, and do they have valid CE certificates?”
    Read the full chat →

    Check its work yourself.

    Every claim links to the EUDAMED or FDA record it came from. If it's not in the data, the assistant says so — it never fills gaps from memory.

    Start researching — free
    10 free messages every month · Pro from €49/mo with 250 messages, API & MCP access — see pricing

    What can you ask it?

    The assistant is built for the research jobs regulatory professionals actually do. Verification: "Is this manufacturer registered in EUDAMED, and are their CE certificates still valid?" — procurement and distributor teams use this to vet suppliers. Predicate research: "Find recent 510(k) clearances for product code DQA and summarize their predicates" — the groundwork of every FDA submission. Competitive analysis: "Which devices has this competitor registered in the EU, and with which notified bodies?" — state-of-the-art and market landscape work. Post-market data: "Pull adverse event trends and recalls for infusion pumps since 2024" — the vigilance groundwork for a PSUR report.

    One important boundary: the assistant researches what is in the data. It does not give regulatory advice — for classification strategy or submission questions, talk to a consultant. Every answer is generated from tool calls against the BEUDAMED database and cites its records; data freshness follows our EUDAMED crawl and FDA import schedules. Prefer working programmatically? The same tools are available via our REST API and MCP server.