510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Mir - Medical International Research S.p.A.

ROMA Roma, IT

MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A. appears in FDA device records in ROMA Roma, IT. FDA records list one 510(k) clearance, no PMA records and one registered establishment. 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
1

510(k) clearance history

FDA records hold 1 510(k) clearance for Mir - Medical International Research S.p.A. in 2018.

Clearances by year, as a table
510(k) clearance decisions for Mir - Medical International Research S.p.A., by decision year
YearClearances
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K181666Smart OneBZHSubstantially Equivalent

Registered establishments

FDA registered establishments for Mir - Medical International Research S.p.A., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
96148603004612204MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A.Viale Luigi Schiavonetti, 270, ROMA 00173 IT2026

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

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