Medisana GmbH

Address:Carl-Schurz-Str. 2,Neuss North Rhine-Westphalia,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

Massager, Therapeutic, Electric (ISA) (3) Oximeter (DQA) (1) System, Measurement, Blood-Pressure, Non-Invasive (DXN) (1) Thermometer, Electronic, Clinical (FLL) (1)

Premarket Exempt

No Yes

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medisana - 04015588920165 Catalog Number : 92016

Device Description : Shiatsu massage cushion

Device Class : 1

Duns Number: 319241873

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

medisana - 04015588920219 Catalog Number : 92021

Device Description : Massage mat with vibration and heat function

Device Class : 1

Duns Number: 319241873

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

Medisana - 04015588995385 Catalog Number : 99538

Device Description : Electronically powered device with a vibrating mode to treat the neck muscles. O Electronically powered device with a vibrating mode to treat the neck muscles. Optionally with heating function by red light. It is typically used for physiotherapie e.g reduce muscular tensions for domestic use.

Device Class :

Duns Number: 319241873

Premarket Exempt : Yes

Product Code : ISA

Prescription Use : No

Device Count : 1

MEDISANA - 04015588996528 Catalog Number : 99652

Device Description : a hand-held, battery-powered, electronic instrument designed to measure :1) the a hand-held, battery-powered, electronic instrument designed to measure :1) the temperature of a patient's ear canal, typically to estimate the internal (core) temperature; and 2) the temperature of the site on the skin (e.g., axilla, forehead), by measurement of body infrared emissions. It typically includes both a skin-surface tip and an intra-aural tip.This device is intended for use in the home or healthcare facility. It is a reusable device

Device Class : 2

Duns Number: 319241873

Premarket Exempt : No

Product Code : FLL

Prescription Use : No

Device Count : 1

medisana - 04015588999765 Catalog Number : 99976

Device Description : Blood Pressure Meter

Device Class : 2

Duns Number: 319241873

Premarket Exempt : No

Product Code : DXN

Prescription Use : No

Device Count : 1

medisana - 04015588999802 Catalog Number : 99980

Device Description : Pulse oximeter

Device Class : 2

Duns Number: 319241873

Premarket Exempt : No

Product Code : DQA

Prescription Use : No

Device Count : 1

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