PLATINUM EXPORTS PTY LTD

PLATINUM EXPORTS PTY LTD

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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

Nebulizer (Direct Patient Interface) (CAF) (2)

Premarket Exempt

Yes

Clear

Aerdilx - 00860004038108 Catalog Number : MCN-S600MD

Device Description : Compressor Nebulizer Machine BlueFull UDI: (01)00860004038108(11)200701(10)120205006

Device Class : 2

Duns Number: 746845295

Premarket Exempt : Yes

Product Code : CAF

Prescription Use : No

Device Count : 1

Aerdilx - 00860004038115 Catalog Number : MCN-S600MD

Device Description : Compressor Nebulizer Machine WhiteFull UDI: (01)00860004038115(11)200701(10)120205006

Device Class : 2

Duns Number: 746845295

Premarket Exempt : Yes

Product Code : CAF

Prescription Use : No

Device Count : 1

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