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MEDISANA GMBH

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30088611233008861123MEDISANA GMBH1N2020-04-25Jagenbergstr 19 Neuss DE 41468

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
04015588987571MEDISANA - 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 device2488633175cservice@medisana.us
04015588995385Medisana - 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.2488633175cservice@medisana.us

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2301911395534137K181503Fingertip Pulse OximeterDQA2018-10-11
2301912064011952K160019U80 Series Upper Arm Electronic Blood Pressure MonitorDXN2016-04-22
2301911220231766K102554AVITA SCANEO IR THERMOMETER MODEL TS4X SERIESFLL2011-03-03

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DQA12018-10-11
DXN12016-04-22
FLL12011-03-03

GUDID#