FDA.reportPublic FDA data

Earmould impression kit

Definition
A collection of non-sterile supplies, instruments, and materials intended to be used to make an accurate impression of the folds and convolutions of cartilage that form the outer ear and its canal (i.e., an earmould). It typically includes a foam or cotton block, a mixing bowl, a spatula, impression liquid and/or powder; it also includes either a syringe or tube to deliver the impression material, or less frequently an impression tray for direct moulding. The mould of the ear is used to manufacture custom-made hearing devices such as hearing aids and earplugs. This is a single-use device.
GUDID devices
67
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00850013007479Soft Medial Mixing TipsEARLENS CORPORATIONIDT042021-06-22
00850013007509Lateral Mixing TipsEARLENS CORPORATIONIDT052021-12-03
E2394521Otoform® AkDreve Otoplastik GmbH4522020-06-05
D239206411egger A/ITE varioInnovation MediTech GmbH206412025-08-29
E2392064111egger A/ITE varioInnovation MediTech GmbH2064112025-08-29
E2392936M1Otoform® A flexDreve Otoplastik GmbH2936M2025-01-20
E2392956M1Otoform® A softXDreve Otoplastik GmbH2956M2025-01-20
E2393206M1Otoform® A softDreve Otoplastik GmbH3206M2025-01-20
E2395041Otoform® KcDreve Otoplastik GmbH5042025-01-13
E2398802AU1Otoform® A softX Dreve Otoplastik GmbH8802AU2024-03-13
E2398802ST1Otoform® A softX Dreve Otoplastik GmbH8802ST2024-03-13
E2398802M1Otoform® A softXDreve Otoplastik GmbH8802M2023-12-18
E23988021Otoform® A softX Dreve Otoplastik GmbH88022023-10-31
00850013007387Impression DispenserEARLENS CORPORATIONIDG012023-06-09
EPRCA4020141Mixing Cannulapro3dure medical GmbHS50 System2023-02-28
E2397431Precise IIDreve Otoplastik GmbH7432022-12-05
EDET033211impression plugs, conicalDETAX GmbH033212022-10-25
E23929361Otoform® A flexDreve Otoplastik GmbH29362022-08-12
E23929561Otoform® A softX Dreve Otoplastik GmbH29562022-08-12
E23929661Otoform® XpandDreve Otoplastik GmbH29662022-08-12
E2392966M1Otoform® XpandDreve Otoplastik GmbH2966M2022-08-12
E23932061Otoform® A soft Dreve Otoplastik GmbH32062022-08-12
E23932101Mixing canulasDreve Otoplastik GmbH32102022-08-12
E2393211Mixing canulasDreve Otoplastik GmbH3212022-08-12
E23932141Mixing canulasDreve Otoplastik GmbH32142022-08-12
E2393221Mixing canulasDreve Otoplastik GmbH3222022-08-12
E23932411T Mixing canulasDreve Otoplastik GmbH32412022-08-12
E23932421T Mixing canulasDreve Otoplastik GmbH32422022-08-12
E23932441T Mixing canulasDreve Otoplastik GmbH32442022-08-12
E23932451T Mixing canulasDreve Otoplastik GmbH32452022-08-12
E23932461T Mixing canulasDreve Otoplastik GmbH32462022-08-12
E23932471T Mixing canulasDreve Otoplastik GmbH32472022-08-12
E2393261Mixing canulasDreve Otoplastik GmbH3262022-08-12
E23932701Mixing canulasDreve Otoplastik GmbH32702022-08-12
E2393271Mixing canulasDreve Otoplastik GmbH3272022-08-12
E239452CN1Otoform® AkDreve Otoplastik GmbH452CN2022-08-12
E239452CNS1Otoform® AkDreve Otoplastik GmbH452CNS2022-08-12
E239454201Otoform® AkDreve Otoplastik GmbH454202022-08-12
E239454301Otoform® Ak XDreve Otoplastik GmbH454302022-08-12
E23945451Otoform® AkDreve Otoplastik GmbH45452022-08-12
E2394545M1Otoform® AkDreve Otoplastik GmbH4545M2022-08-12
E2394561Otoform® AkDreve Otoplastik GmbH4562022-08-12
E2394571Otoform® AkDreve Otoplastik GmbH4572022-08-12
E2394641Otoform® AkDreve Otoplastik GmbH4642022-08-12
E239464CN1Otoform® AkDreve Otoplastik GmbH464CN2022-08-12
E2394701Otoform® Ak XDreve Otoplastik GmbH4702022-08-12
E2394751Otoform® Ak XDreve Otoplastik GmbH4752022-08-12
E2395001Otoform® KcDreve Otoplastik GmbH5002022-08-12
E2395021Otoform® KcDreve Otoplastik GmbH5022022-08-12
E239521121Hardener pasteDreve Otoplastik GmbH521122022-08-12
E239522121Hardener pasteDreve Otoplastik GmbH522122022-08-12
E2395321Impression syringeDreve Otoplastik GmbH5322022-08-12
E2395331Impression syringeDreve Otoplastik GmbH5332022-08-12
E2395341Impression syringeDreve Otoplastik GmbH5342022-08-12
E2395651Impression padsDreve Otoplastik GmbH5652022-08-12
E2395661Impression padsDreve Otoplastik GmbH5662022-08-12
E23956711Vented Impression padsDreve Otoplastik GmbH56712022-08-12
E23956721Vented Impression padsDreve Otoplastik GmbH56722022-08-12
E23956731Vented Impression padsDreve Otoplastik GmbH56732022-08-12
E23956741Vented Impression padsDreve Otoplastik GmbH56742022-08-12
E23956751Vented Impression padsDreve Otoplastik GmbH56752022-08-12
E23988011Otoform® A softX Dreve Otoplastik GmbH88012022-08-12
E2398801M1Otoform® A softX Dreve Otoplastik GmbH8801M2022-08-12
07613275561577Phonak BrandSonova AG054-07672021-11-01
07613275561584Phonak BrandSonova AG054-07682021-11-01
07613275561591Phonak BrandSonova AG054-07692021-11-01
08800038032392EZXIMEDICOM CO., LTD.XST1000B2019-05-09