Medikro Oy

Address:Pioneerinkatu 3,Kuopio Pohjois-Savo,FI

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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) (4) Mouthpiece, Breathing (BYP) (2) Tubing, Pressure And Accessories (BYX) (2) Calibrator, Volume, Gas (BXW) (1) Clip, Nose (BXJ) (1)

Premarket Exempt

No Yes

Clear

M9474, Medikro® Calibration Syringe, 3000 ml - 06420099000387 Catalog Number :

Device Class : 1

Duns Number: 369263660

Premarket Exempt : Yes

Product Code : BXW

Prescription Use : Yes

Device Count : 1

M9264-200, Pressure Tube - 06420099000486 Catalog Number :

Device Class : 1

Duns Number: 369263660

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 1

M9256, SpiroSafe Disposable Flow Transducer - 06420099000554 Catalog Number :

Device Class :

Duns Number: 369263660

Premarket Exempt : No

Product Code : BYP

Prescription Use : Yes

Device Count : 100

M9256, SpiroSafe Disposable Flow Transducer - 06420099000561 Catalog Number :

Device Class :

Duns Number: 369263660

Premarket Exempt : No

Product Code : BYP

Prescription Use : Yes

Device Count : 90

M9227, Nose Clip - 06420099000677 Catalog Number :

Device Class :

Duns Number: 369263660

Premarket Exempt : Yes

Product Code : BXJ

Prescription Use : Yes

Device Count : 100

M91227-25, Medikro® Grip - 06420099000691 Catalog Number :

Device Class :

Duns Number: 369263660

Premarket Exempt : Yes

Product Code : BYX

Prescription Use : Yes

Device Count : 25

M913, Medikro® Nano - 06420099000820 Catalog Number :

Device Class : 2

Duns Number: 369263660

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

M915, Medikro® Pro - 06420099000837 Catalog Number :

Device Class : 2

Duns Number: 369263660

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

M914, Medikro® Primo - 06420099000851 Catalog Number :

Device Class : 2

Duns Number: 369263660

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

M915-PCD, PCD Spirometer Kit - 06420099001094 Catalog Number :

Device Class : 2

Duns Number: 369263660

Premarket Exempt : No

Product Code : BZG

Prescription Use : Yes

Device Count : 1

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