Heine Optotechnik GmbH & Co. KG

Address:DORNIERSTR. 6,GILCHING 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

Blood Pressure Cuff (DXQ) (9) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (1)

Premarket Exempt

No Yes

Clear

HEINE GAMMA® GP Practice Kit - 04053755136643 Catalog Number : M-000.09.556

Device Class : 2

Duns Number: 315274563

Premarket Exempt : Yes

Product Code : DXN

Prescription Use : No

Device Count : 1

HEINE GAMMA® Single-tube cuff - 04053755136742 Catalog Number : M-000.09.615

Device Class : 2

Duns Number: 315274563

Premarket Exempt : Yes

Product Code : DXQ

Prescription Use : No

Device Count : 1

HEINE GAMMA® Single-tube cuff - 04053755136759 Catalog Number : M-000.09.619

Device Class : 2

Duns Number: 315274563

Premarket Exempt : Yes

Product Code : DXQ

Prescription Use : No

Device Count : 1

HEINE GAMMA® Twin-tube cuff - 04053755136797 Catalog Number : M-000.09.625

Device Class : 2

Duns Number: 315274563

Premarket Exempt : Yes

Product Code : DXQ

Prescription Use : No

Device Count : 1

HEINE GAMMA® Twin-tube cuff - 04053755136803 Catalog Number : M-000.09.629

Device Class : 2

Duns Number: 315274563

Premarket Exempt : Yes

Product Code : DXQ

Prescription Use : No

Device Count : 1

HEINE GAMMA® Single-tube bladder - 04053755136834 Catalog Number : M-000.09.664

Device Class : 2

Duns Number: 315274563

Premarket Exempt : Yes

Product Code : DXQ

Prescription Use : No

Device Count : 1

HEINE GAMMA® Single-tube cuff - 04053755136926 Catalog Number : M-000.09.700

Device Class : 2

Duns Number: 315274563

Premarket Exempt : Yes

Product Code : DXQ

Prescription Use : No

Device Count : 1

HEINE GAMMA® Single-tube cuff - 04053755136940 Catalog Number : M-000.09.702

Device Class : 2

Duns Number: 315274563

Premarket Exempt : Yes

Product Code : DXQ

Prescription Use : No

Device Count : 1

HEINE GAMMA® Twin-tube cuff - 04053755136957 Catalog Number : M-000.09.703

Device Class : 2

Duns Number: 315274563

Premarket Exempt : Yes

Product Code : DXQ

Prescription Use : No

Device Count : 1

HEINE GAMMA® Single-tube cuff - 04053755136964 Catalog Number : M-000.09.704

Device Class : 2

Duns Number: 315274563

Premarket Exempt : Yes

Product Code : DXQ

Prescription Use : No

Device Count : 1

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