BIOS SRL

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

Massager, Vacuum, Radio Frequency Induced Heat (PBX) (7) Powered Laser Surgical Instrument (GEX) (3)

Premarket Exempt

Clear

THERMI 250 - 08052049500005 Catalog Number :

Device Class : 2

Duns Number: 443571203

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

SUPERBIUM - 08052049500012 Catalog Number :

Device Class : 2

Duns Number: 443571203

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

SQUARE EPIL ALEX + Nd:YAG - 08052049500029 Catalog Number :

Device Class : 2

Duns Number: 443571203

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

BIOREVITAL RF MED - 08052049500043 Catalog Number :

Device Class : 2

Duns Number: 443571203

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

NUERA - 08052049500050 Catalog Number :

Device Class : 2

Duns Number: 443571203

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

SPLENDOR X ALEX + Nd:YAG - 08052049500067 Catalog Number :

Device Class : 2

Duns Number: 443571203

Premarket Exempt : No

Product Code : GEX

Prescription Use : Yes

Device Count : 1

NUERA TIGHT - 08052049500104 Catalog Number :

Device Class : 2

Duns Number: 443571203

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

NUERA TIGHT - 08052049500111 Catalog Number :

Device Class : 2

Duns Number: 443571203

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

FEMINESS tip - 08052049500135 Catalog Number :

Device Class : 2

Duns Number: 443571203

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

FEMINESS - 08052049500197 Catalog Number :

Device Class : 2

Duns Number: 443571203

Premarket Exempt : No

Product Code : PBX

Prescription Use : Yes

Device Count : 1

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