AEA SRL

Address:Via Fiume 16,Angeli di Rosora Ancona,IT

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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

Syringe, Piston (FMF) (7) System/Device, Pharmacy Compounding (NEP) (3) Set, I.V. Fluid Transfer (LHI) (1)

Premarket Exempt

No Yes

Clear

APOTECA - 05060304050199 Catalog Number :

Device Class : 2

Duns Number: 429415227

Premarket Exempt : Yes

Product Code : NEP

Prescription Use : No

Device Count : 1

APOTECA - 05060304050243 Catalog Number :

Device Description : Automatic system for compouding of non-hazardous drugs for pedriatic patients

Device Class : 2

Duns Number: 429415227

Premarket Exempt : Yes

Product Code : NEP

Prescription Use : No

Device Count : 1

APOTECAsyringe - 05060304050250 Catalog Number :

Device Description : Automatic system for filling syringes

Device Class : 2

Duns Number: 429415227

Premarket Exempt : Yes

Product Code : NEP

Prescription Use : Yes

Device Count : 1

APOTECA - 05060304050823 Catalog Number : SDL-01-STD

Device Description : Transfer of liquid from a bag to syringes with APOTECAsyringe system

Device Class : 2

Duns Number: 429415227

Premarket Exempt : No

Product Code : LHI, FMF

Prescription Use : Yes

Device Count : 1

APOTECA - 05060304050960 Catalog Number :

Device Description : Pharmacy compounding dosing device

Device Class : 2

Duns Number: 429415227

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

APOTECA - 05060304050977 Catalog Number :

Device Description : Pharmacy compounding dosing device

Device Class : 2

Duns Number: 429415227

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

APOTECA - 05060304050984 Catalog Number :

Device Description : Pharmacy compounding dosing device

Device Class : 2

Duns Number: 429415227

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

APOTECA - 05060304050991 Catalog Number :

Device Description : Pharmacy compounding dosing device

Device Class : 2

Duns Number: 429415227

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

APOTECA - 05060304051004 Catalog Number :

Device Description : Pharmacy compounding dosing device

Device Class : 2

Duns Number: 429415227

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

APOTECA - 05060304051011 Catalog Number :

Device Description : Pharmacy compounding dosing device

Device Class : 2

Duns Number: 429415227

Premarket Exempt : No

Product Code : FMF

Prescription Use : Yes

Device Count : 1

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