| Primary Device ID | EADF034106002172068681 | 
| NIH Device Record Key | f61f1a19-51d5-49c7-80a9-7c244ae9edfa | 
| Commercial Distribution Status | In Commercial Distribution | 
| Brand Name | audifon | 
| Version Model Number | audifon APP 1.4.2 | 
| Catalog Number | 03410600217206868 | 
| Company DUNS | 344064407 | 
| Company Name | audifon GmbH & Co. KG | 
| Device Count | 1 | 
| DM Exempt | false | 
| Pre-market Exempt | true | 
| MRI Safety Status | Labeling does not contain MRI Safety Information | 
| Human Cell/Tissue Product | false | 
| Device Kit | false | 
| Device Combination Product | false | 
| Single Use | false | 
| Lot Batch | false | 
| Serial Number | true | 
| Manufacturing Date | true | 
| Expiration Date | false | 
| Donation Id Number | false | 
| Contains Natural Rubber Latex | false | 
| Labeled No Natural Rubber Latex | false | 
| RX Perscription | true | 
| OTC Over-The-Counter | false | 
| Device Issuing Agency | Device ID | 
|---|---|
| HIBCC | EADF034106002172068681 [Primary] | 
| ETW | Calibrator, Hearing Aid / Earphone And Analysis Systems | 
| Steralize Prior To Use | false | 
| Device Is Sterile | false | 
| Public Version Status | New | 
| Device Record Status | Published | 
| Public Version Number | 1 | 
| Public Version Date | 2022-10-31 | 
| Device Publish Date | 2022-10-21 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  AUDIFON  79043076  not registered Dead/Abandoned | Audifon GmbH & Co. KG 2007-05-10 | 
|  AUDIFON  79016369  3154377 Dead/Cancelled | Audifon GmbH & Co. KG 2005-04-11 | 
|  AUDIFON  77980719  3885436 Live/Registered | audifon GmbH & Co. KG 2009-02-17 | 
|  AUDIFON  77671744  not registered Dead/Abandoned | audifon GmbH & Co. KG 2009-02-17 |