sfm medical devices GmbH

Address:Brueckenstrasse 5,Waechtersbach Hesse,DE

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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

Set, I.V. Fluid Transfer (LHI) (3) Cannula, Surgical, General & Plastic Surgery (GEA) (1) System/Device, Pharmacy Compounding (NEP) (1)

Premarket Exempt

No Yes

Clear

Cannula for subcutaneous Implant/ pellet administration - 04063574100008 Catalog Number :

Device Description : Cannula for subcutaneous Implant/ pellet administration, 14 G x 50mm

Device Class : 1

Duns Number: 315549311

Premarket Exempt : Yes

Product Code : GEA

Prescription Use : Yes

Device Count : 1

nextaro® - 04063574100015 Catalog Number :

Device Description : nextaro® Transfer System (20/20 with 15 µm filter, nominal)

Device Class : 2

Duns Number: 315549311

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

nextaro® va - 04063574100022 Catalog Number :

Device Description : nextaro® va (with 15µm filter, nominal for a 20mm vial)

Device Class : 2

Duns Number: 315549311

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

nextaro® - 04063574200012 Catalog Number :

Device Description : nextaro® Transfer System (20/20 with 15 µm filter, nominal)

Device Class : 2

Duns Number: 315549311

Premarket Exempt : No

Product Code : LHI

Prescription Use : Yes

Device Count : 1

Filter 20µm - 04063574848801 Catalog Number :

Device Class : 2

Duns Number: 315549311

Premarket Exempt : Yes

Product Code : NEP

Prescription Use : No

Device Count : 1

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