Orfit Industries NV

Address:9A, VOSVELD,WIJNEGEM Antwerpen,BE

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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

Accelerator, linear, medical (IYE) (10)

Premarket Exempt

Clear

Orfit Industries - 05420028771471 Catalog Number :

Device Description : Head mask

Device Class : 2

Duns Number: 283679900

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Orfit Industries - 05420028772461 Catalog Number :

Device Description : DUON Head ,Neck ,Shoulder Mask

Device Class : 2

Duns Number: 283679900

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Orfit Industries - 05420028772577 Catalog Number :

Device Class : 2

Duns Number: 283679900

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Orfit Industries - 05420028772584 Catalog Number :

Device Description : DUON UH-HEAD MASK 2.4MM MICRO+

Device Class : 2

Duns Number: 283679900

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Orfit Industries - 05420028775219 Catalog Number :

Device Description : 5pt H&N&S Mask -No Nose Hole

Device Class : 2

Duns Number: 283679900

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Orfit Industries - 05420028776865 Catalog Number :

Device Description : Push pin set for Duon masks

Device Class : 2

Duns Number: 283679900

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Orfit Industries - 05420028777510 Catalog Number :

Device Description : Fraxion Head Mask (10 pcs.) Efficast 2 mm micro

Device Class : 2

Duns Number: 283679900

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Orfit Industries - 05420028779903 Catalog Number :

Device Description : Duon Insert Gray

Device Class : 2

Duns Number: 283679900

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Orfit Industries - 05420028780145 Catalog Number :

Device Description : Duon Pin Orange

Device Class : 2

Duns Number: 283679900

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

Orfit Industries - 05420028782477 Catalog Number :

Device Description : DUON® Hybrid Open Face Mask - Head

Device Class : 2

Duns Number: 283679900

Premarket Exempt : No

Product Code : IYE

Prescription Use : No

Device Count : 1

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