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) (5) Ophthalmoscope, Battery-Powered (HLJ) (3) Otoscope (ERA) (1) Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

No Yes

Clear

ri-san® saffron, adult size hook cuff - 04045396002548 Catalog Number : 1521

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

ri-san® saffron, adult size velcro cuff - 04045396002555 Catalog Number : 1522

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

ri-san® green, adult size bandage cuff - 04045396002562 Catalog Number : 1525

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

ri-san® green, adult size hook cuff - 04045396002579 Catalog Number : 1526

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

ri-san® green, adult size velcro cuff - 04045396002586 Catalog Number : 1527

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

ri-gital®, digital thermometer incl. button cell battery - 04045396002722 Catalog Number : 1850

Device Description : The thermometers are for measuring the body temperature.

Device Class : 2

Duns Number: 537208717

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

uni® I otoscope vacuum 2.7 V, C-handle - 04045396002739 Catalog Number : 2010

Device Description : The Riester otoscope has been produced with examination of the auditory canal in

Device Class : 1

Duns Number: 537208717

Premarket Exempt : No

Product Code : ERA

Prescription Use : No

Device Count : 1

uni® II May-ophthalmoscope XL 2.5 V - 04045396002746 Catalog Number : 2020

Device Description : The Riester ophthalmoscope has been designed for the examination of the eye and

Device Class : 2

Duns Number: 537208717

Premarket Exempt : No

Product Code : HLJ

Prescription Use : No

Device Count : 1

uni® III otoscope/May-ophthalmoscope Vacuum 2.7 V - 04045396002753 Catalog Number : 2030

Device Description : The Riester otoscope has been produced with examination of the auditory canal in

Device Class : 2

Duns Number: 537208717

Premarket Exempt : No

Product Code : HLJ

Prescription Use : No

Device Count : 1

econom® Vac. 2.7 V / XL 2.5 V, C-handle - 04045396002760 Catalog Number : 2050

Device Description : The Riester otoscope has been produced with examination of the auditory canal in

Device Class : 2

Duns Number: 537208717

Premarket Exempt : No

Product Code : HLJ

Prescription Use : No

Device Count : 1

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