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01 1SILBIONE BIOMEDICAL HCRU D550

02 1SILBIONE BIOMEDICAL LSR D135-SE

03 1SILBIONE BIOMEDICAL LSR D135-TB

04 1SILBIONE BIOMEDICAL LSR D340

05 1SILBIONE® BIOMEDICAL HCRA D500 SERIES

06 1SILBIONE® BIOMEDICAL LSR D100 SERIES

07 1SILBIONE® BIOMEDICAL LSR HI-DUROMETER D300 SERIES

08 1SILBIONE™ BIO DV 10K EP

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PharmaCompass

04

euroPLX 90 Lisbon
Not Confirmed
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08

SILBIONE™ BIO DV 10K EP

euroPLX 90 Lisbon
Not Confirmed
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SILBIONE™ BIO DV 10K EP

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euroPLX 90 Lisbon
Not Confirmed

GDUFA

DMF Review : N/A

Rev. Date :

Pay. Date :

DMF Number : 43171

Submission : 2025-12-30

Status : Active

Type : IV

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