Vyaire Medical GmbH

Address:LEIBNIZSTRASSE 7,HOECHBERG Bavaria,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

Spirometer, Diagnostic (BZG) (7) Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase (CCJ) (1) Monitor, Airway Pressure (Includes Gauge And/Or Alarm) (CAP) (1) Oximeter (DQA) (1)

Premarket Exempt

No Yes

Clear

Micro Medical - 54250892902994 Catalog Number : 36-ML3535 MK8-STK

Device Description : MicroLoop

Device Class : 2

Duns Number: 329769991

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Micro Medical - 54250892904196 Catalog Number : 36-ML3535 MK8-REGION 2&3

Device Description : MicroLoop

Device Class : 2

Duns Number: 329769991

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Micro Medical - 54250892904202 Catalog Number : 36-ML3535 MK8-REGION4

Device Description : MicroLoop

Device Class : 2

Duns Number: 329769991

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Vyaire - 54250892904899 Catalog Number : V-178501

Device Description : Vyntus WALK

Device Class : 2

Duns Number: 329769991

Premarket Exempt : No

Product Code : DQA

Prescription Use : Yes

Device Count : 1

Vyaire - 54250892905452 Catalog Number : 36-ML2525-STK

Device Description : SpiroUSB

Device Class : 2

Duns Number: 329769991

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Vyaire - 54250892905469 Catalog Number : 36-ML3535 MK8-STK

Device Description : MicroLoop

Device Class : 2

Duns Number: 329769991

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Vyaire - 54250892905476 Catalog Number : 36-ML3535 MK8-Region 2&3

Device Description : MicroLoop

Device Class : 2

Duns Number: 329769991

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Vyaire - 54250892905483 Catalog Number : 36-ML3535 MK8-Region 4

Device Description : MicroLoop

Device Class : 2

Duns Number: 329769991

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

Vyaire - 54250892905490 Catalog Number : 36-RPM01-STK

Device Description : MicroRPM

Device Class : 2

Duns Number: 329769991

Premarket Exempt : No

Product Code : CAP

Prescription Use : Yes

Device Count : 1

Vyaire - 54250892905506 Catalog Number : 36-MC02-STK

Device Description : MicroCO

Device Class : 2

Duns Number: 329769991

Premarket Exempt : No

Product Code : CCJ

Prescription Use : Yes

Device Count : 1

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