Rudolf Riester GmbH

Address:BRUCKSTRASSE 31,JUNGINGEN Baden-Wurttemberg,DE

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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) (4) Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (3) Otoscope (ERA) (3)

Premarket Exempt

No Yes

Clear

RVS-100,NIBP(Riester)+SpO2(Riester) + Pred. Temp - 04045396214699 Catalog Number : 1960-RRBXG

Device Description : The RVS-100 vital signs monitor is intended to be used for monitoring, displayin

Device Class : 2

Duns Number: 537208717

Premarket Exempt : No

Product Code : MWI

Prescription Use : No

Device Count : 1

EliteVue otoscope set, LED, 3.5V, with C-handle, 1 - 04045396214958 Catalog Number : 2211-203.002

Device Description : The Riester otoscope is produced for illumination and examination of the auditor

Device Class : 1

Duns Number: 537208717

Premarket Exempt : No

Product Code : ERA

Prescription Use : No

Device Count : 1

Velcro cuff 1 tube, adults, - 04045396215511 Catalog Number : 107.005

Device Description : Riester cuffs are used to generate pressure when measuring blood pressure.

Device Class : 2

Duns Number: 537208717

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 1

Velcro cuff 1 tube, obese, - 04045396215528 Catalog Number : 122.005

Device Description : Riester cuffs are used to generate pressure when measuring blood pressure.

Device Class : 2

Duns Number: 537208717

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 1

Velcro cuff 1 tube, children, with - 04045396215542 Catalog Number : 129.006

Device Description : Riester cuffs are used to generate pressure when measuring blood pressure.

Device Class : 2

Duns Number: 537208717

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 1

Velcro cuff 1 tube, newborns, - 04045396215566 Catalog Number : 134.002

Device Description : Riester cuffs are used to generate pressure when measuring blood pressure.

Device Class : 2

Duns Number: 537208717

Premarket Exempt : No

Product Code : DXQ

Prescription Use : Yes

Device Count : 1

ri-scope® L oto- L2/ophthal. L2, LED/XL 3.5 V/120 - 04045396215801 Catalog Number : 3750.015

Device Description : The Riester otoscope is produced for illumination and examination of the auditor

Device Class : 1

Duns Number: 537208717

Premarket Exempt : No

Product Code : ERA

Prescription Use : No

Device Count : 1

RVS-100 - 04045396215863 Catalog Number : 1960-RNBPU

Device Class : 2

Duns Number: 537208717

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

ri-scope® L F.O. Oto- L3/Ophthalm. L2, LED 3,5V, C - 04045396215955 Catalog Number : 3746-203.014

Device Description : The Riester otoscope is produced for illumination and examination of the auditor

Device Class : 1

Duns Number: 537208717

Premarket Exempt : No

Product Code : ERA

Prescription Use : No

Device Count : 1

RVS-100 - 04045396216327 Catalog Number : 1960-RRXXU

Device Description : Vital Sign Monitoring

Device Class : 2

Duns Number: 537208717

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

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