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

System, Measurement, Blood-Pressure, Non-Invasive (DXN) (4) Blood Pressure Cuff (DXQ) (3) Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) (MWI) (1) Otoscope (ERA) (1) Stethoscope, Manual (LDE) (1)

Premarket Exempt

No Yes

Clear

Stethoscope cardiophon 2.0, burgundy - 04045396000186 Catalog Number : 4240-04

Device Description : Stethoscopes are sound-conducting instruments to be used for auscultation of bod Stethoscopes are sound-conducting instruments to be used for auscultation of body and organ sounds, especially of heart and lung; meaning they are used in order to diagnose illness of internal organs.In medical science, doctors or other trained medical professionals use a stethoscope in order to assess sounds and noises linked with the function of heart, lung and bowel. During blood pressure measurement, a stethoscope is used to capture Korotkow blood flow murmur (Korotkow sounds) leading to determination of systolic and diastolic blood pressure.

Device Class : 1

Duns Number: 537208717

Premarket Exempt : No

Product Code : LDE

Prescription Use : No

Device Count : 1

RVS-100 - 04045396000216 Catalog Number : 1960-RNBXU

Device Description : Vital Signs Monitoring

Device Class : 2

Duns Number: 537208717

Premarket Exempt : No

Product Code : MWI

Prescription Use : Yes

Device Count : 1

RVS-200, NIBP(Riester) +SpO2(Nellcor) + Pred. Temp - 04045396000339 Catalog Number : 1961-RNBXU

Device Description : The RVS-200 Wall Diagnostic Station and RVS-200 Extension Module were produced f The RVS-200 Wall Diagnostic Station and RVS-200 Extension Module were produced for use with various instrument heads fornon-invasive diagnosis of ENT and Ophthalmology.

Device Class : 1

Duns Number: 537208717

Premarket Exempt : Yes

Product Code : ERA

Prescription Use : No

Device Count : 1

diplomat-presameter® desk, light grey, adult size bandage cuff - 04045396001275 Catalog Number : 1000

Device Description : Mercury sphygmomanometers for non invasive measurement of arterial blood pressure.

Device Class : 2

Duns Number: 537208717

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

minimus® II black, adult size bandage cuff - 04045396001794 Catalog Number : 1310

Device Description : Aneroid sphygmomanometers for non invasive measurement of arterial blood pressure.

Device Class : 2

Duns Number: 537208717

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

minimus® II black, adult size hook cuff - 04045396001800 Catalog Number : 1311

Device Description : Aneroid sphygmomanometers for non invasive measurement of arterial blood pressure.

Device Class : 2

Duns Number: 537208717

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

minimus® II black, adult size velcro cuff - 04045396001817 Catalog Number : 1312

Device Description : Aneroid sphygmomanometers for non invasive measurement of arterial blood pressure.

Device Class : 2

Duns Number: 537208717

Premarket Exempt : No

Product Code : DXQ

Prescription Use : No

Device Count : 1

minimus® III, adult size bandage cuff - 04045396001855 Catalog Number : 1340

Device Description : Aneroid sphygmomanometers for non invasive measurement of arterial blood pressure.

Device Class : 2

Duns Number: 537208717

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

minimus® III, adult size hook cuff - 04045396001862 Catalog Number : 1341

Device Description : Aneroid sphygmomanometers for non invasive measurement of arterial blood pressure.

Device Class : 2

Duns Number: 537208717

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

minimus® III, adult size velcro cuff - 04045396001879 Catalog Number : 1342

Device Description : Aneroid sphygmomanometers for non invasive measurement of arterial blood pressure.

Device Class : 2

Duns Number: 537208717

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

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