FDA.report

HANSATON

Primary DI
07613389143232
Brand
HANSATON
Company
Hansaton Akustik GmbH
Model
058-5227
Catalog number
058-5227
Device description
USB V3.6.1 Fitting Software Hansaton Scout
Published
2018-12-10
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Contact Domains

Product Codes

CodeName
OSMHearing aid, air conduction with wireless technology

Product Code Classifications

CodeDeviceSpecialtyClass
OSMHearing Aid, Air-Conduction With Wireless Technology, PrescriptionEar, Nose, Throat2

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
07613389143232PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
07613389143232076133891432327613389143232

GMDN Terms

TermDefinition
Audiometric/hearing device softwareA software program intended to assist with the evaluation of a patient’s hearing capability and/or hearing assistive devices. It may be used by healthcare professionals in a healthcare facility or by the patient in the home, and usually runs on an off-the-shelf portable computerized device (e.g., smartphone, tablet).

Sterilization Methods

Method

Contacts

PhoneEmail
+49402980110info@hansaton.de

Regulatory Flags

DUNS number
316040146
Device count
1
DM exempt
true
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
04250185560462Hansaton075-5841075-58412019-04-12
04250185560479Hansaton075-5841-11075-5841-112019-04-12
04250185543007Hansaton89345893452016-09-23
04250185543014Hansaton89346893462016-09-23
04250185543021Hansaton89347893472016-09-23
04250185558216HANSATON075-5002075-50022018-12-10
04250185558223HANSATON075-5003075-50032018-12-10
04250185558230Hansaton071-5001071-50012016-09-23
07613389088717HANSATON075-5102-11075-5102-112018-12-10
07613389088731HANSATON075-5103-11075-5103-112018-12-10
07613389088755HANSATON075-5107-11075-5107-112018-12-10
07613389088779HANSATON075-5108-11075-5108-112018-12-10
04250185560493Hansaton050-6180-U3050-6180-U32019-03-19
04250185560509Hansaton050-6181-U3050-6181-U32019-03-19
04250185560516Hansaton050-6182-U3050-6182-U32019-03-19
04250185560523Hansaton050-6183-U3050-6183-U32019-03-19
04250185560530Hansaton050-6184-U4050-6184-U42019-03-19
04250185560547Hansaton050-6185-U3050-6185-U32019-03-19
04250185560554Hansaton050-6186-U3050-6186-U32019-03-19
04250185560561Hansaton050-6187-U3050-6187-U32019-03-19

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
07613389755763Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389755770Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389759112Phonak Audéo E90-Sphere Sonova AGOSM2026-03-17
07613389759129Phonak Audéo E70-Sphere Sonova AGOSM2026-03-17
07613389759136Phonak Audéo E50-Sphere Sonova AGOSM2026-03-17
07613389759150Phonak Audéo E-R Trial Sonova AGOSM2026-03-17
07613389759174Phonak Audéo ESphereTrial Sonova AGOSM2026-03-17
07613389761917Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761924Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761931Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761948Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761955Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761962Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761979Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761986Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389761993Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389762006Phonak Audéo E30-RSonova AGOSM2026-03-17
07613389762013Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762020Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762037Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762044Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762051Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762068Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762075Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762082Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762099Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762105Phonak Audéo E50-RSonova AGOSM2026-03-17
07613389762143Phonak Audéo E70-R Sonova AGOSM2026-03-17
07613389762150Phonak Audéo E70-R Sonova AGOSM2026-03-17
07613389762167Phonak Audéo E70-R Sonova AGOSM2026-03-17