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Bioloren SRL

SARONNO Varese, IT

BIOLOREN SRL appears in FDA device records in SARONNO Varese, IT. FDA records list 3 510(k) clearances between and , 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
3
PMA records
0
Recall records
0
Registered establishments
1

510(k) clearance history

FDA records hold 3 510(k) clearances for Bioloren SRL between 2011 and 2018. The busiest year on record is 2011, with 1. The most recent is 2018, with 1.

Clearances by year, as a table
510(k) clearance decisions for Bioloren SRL, by decision year
YearClearances
20111
20131
20181
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K173643Trilor Disks, Blocks and ArchesEBFSubstantially Equivalent
K121735FIBER DISK AND BLOCK PERMANENT, TRINIAEBFSubstantially Equivalent
K112186FIBER DISK AND BLOCKEBGSubstantially Equivalent

Registered establishments

FDA registered establishments for Bioloren SRL, with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30032318223003231822BIOLOREN SRLVIA ALESSANDRO VOLTA 59, SARONNO Varese IT-21047 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