510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Medovate Limited

Bury St Edmunds Suffolk, GB

MEDOVATE LIMITED appears in FDA device records in Bury St Edmunds Suffolk, GB. FDA records list one 510(k) clearance, no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
1
PMA records
0
Recall records
0
Registered establishments
2

510(k) clearance history

FDA records hold 1 510(k) clearance for Medovate Limited in 2023.

Clearances by year, as a table
510(k) clearance decisions for Medovate Limited, by decision year
YearClearances
20231
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K230083SAFIRAFRNSubstantially Equivalent

Registered establishments

FDA registered establishments for Medovate Limited, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30165097583016509758MEDOVATE LIMITED96 Hampstead Avenue, Bury St Edmunds Suffolk IP28 7AS GB2026
30458098693045809869MEDOVATE LLC200 Texas Ave, Brownsville, TX 78521 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

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What MDM checks, and what it does not

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Data as of , FDA export datePage updated Source: openFDA, public domain