FDA.reportPublic FDA data

Earmould, custom-made

Definition
A custom-made device designed to fit in an individual ear, made from an impression of that ear, and through which the acoustic output from a hearing aid is conveyed to the eardrum, or in which transducer components of a hearing aid are aligned. It is made of synthetic polymer materials. This is a reusable device.
GUDID devices
828
Last updated
2026-03-05 19:59:30

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
EDET030161medicalprint shell beige 2.0 1000gDETAX GmbH030162026-02-25
E239904001FotoTec® DLP.CDreve Otoplastik GmbH904002026-01-30
E239905001FotoTec® DLP.CDreve Otoplastik GmbH905002026-01-30
E239361001FotoTec® DLP.BDreve Otoplastik GmbH361002022-09-15
E239906001FotoTec® DLP.CDreve Otoplastik GmbH906002026-01-15
EDET045581medicalprint nobreak blue-transparent 1000gDETAX GmbH045582025-12-22
EDET045631medicalprint nobreak dark grey1000gDETAX GmbH045632025-12-22
EDET045641medicalprint nobreak green opaque 1000gDETAX GmbH045642025-12-22
EDET045681medicalprint nobreak dark neon yellow 1000gDETAX GmbH045682025-12-22
EDET045691medicalprint nobreak purple 1000gDETAX GmbH045692025-12-22
EDET045701medicalprint nobreak red-transparent 1000gDETAX GmbH045702025-12-22
EDET045741medicalprint nobreak white 1000gDETAX GmbH045742025-12-22
EDET046311medicalprint nobreak orange-transparent 1000gDETAX GmbH045312025-12-22
EDET046331medicalprint coat 300mlDETAX GmbH046332025-12-22
EDET045591medicalprint nobreak brown 1000gDETAX GmbH045592025-12-17
E239903001FotoTec® DLP.CDreve Otoplastik GmbH903002025-07-09
E239908001FotoTec® DLP.CDreve Otoplastik GmbH908002025-07-09
E2399095011FotoTec® DLP.CDreve Otoplastik GmbH9095012025-07-09
E239901001FotoTec® DLP.CDreve Otoplastik GmbH901002025-04-02
EDET028921bioplast 25 shore 8 x 50mlDETAX GmbH028922024-08-28
EDET038421luxaprint 3D shell white 500gDETAX GmbH038422024-08-28
EDET042311detax softwear 2.0 rose 40 8 x 50 ml DETAX GmbH042312024-08-28
E239282081Biopor® AB Dreve Otoplastik GmbH282082024-05-08
E23928208M1Biopor® AB Dreve Otoplastik GmbH28208M2024-05-08
E239282091Biopor® AB Dreve Otoplastik GmbH282092024-05-08
E23928209M1Biopor® AB Dreve Otoplastik GmbH28209M2024-05-08
E239282141Biopor® AB Dreve Otoplastik GmbH282142024-05-08
E23928214M1Biopor® AB Dreve Otoplastik GmbH28214M2024-05-08
E239282161Biopor® AB Dreve Otoplastik GmbH282162024-05-08
E23928216M1Biopor® AB Dreve Otoplastik GmbH28216M2024-05-08
E239282171Biopor® AB Dreve Otoplastik GmbH282172024-05-08
E23928217M1Biopor® AB Dreve Otoplastik GmbH28217M2024-05-08
E23928322M1Biopor® AB Dreve Otoplastik GmbH28322M2024-04-30
E239281141Biopor® AB Dreve Otoplastik GmbH281142024-04-29
E23928114M1Biopor® AB Dreve Otoplastik GmbH28114M2024-04-29
E239281171Biopor® AB Dreve Otoplastik GmbH281172024-04-29
E23928117M1Biopor® AB Dreve Otoplastik GmbH28117M2024-04-29
E239282071Biopor® AB Dreve Otoplastik GmbH282072024-04-29
E23928207M1Biopor® AB Dreve Otoplastik GmbH28207M2024-04-29
E239282151Biopor® AB Dreve Otoplastik GmbH282152024-04-29
E23928215M1Biopor® AB Dreve Otoplastik GmbH28215M2024-04-29
E239283031Biopor® AB Dreve Otoplastik GmbH283032024-04-29
E23928303M1Biopor® AB Dreve Otoplastik GmbH28303M2024-04-29
E239283121Biopor® AB Dreve Otoplastik GmbH283122024-04-29
E23928312M1Biopor® AB Dreve Otoplastik GmbH28312M2024-04-29
E239283221Biopor® AB Dreve Otoplastik GmbH283222024-04-29
E239283321Biopor® AB Dreve Otoplastik GmbH283322024-04-29
E23928332M1Biopor® AB Dreve Otoplastik GmbH28332M2024-04-29
E239283621Biopor® AB Dreve Otoplastik GmbH283622024-04-29
E23928362M1Biopor® AB Dreve Otoplastik GmbH28362M2024-04-29
EPRCA0034150otosil SL-1pro3dure medical GmbH250 g - Clear Transparent 2023-10-18
EPRCA0034151otosil SL-1pro3dure medical GmbH100 g - Clear Transparent 2023-10-18
EPRCA0034160otosil SL-1 I MSIpro3dure medical GmbH250 g - Clear Transparent 2023-10-18
EPRCA0034300otosil protect 50 I MSI pro3dure medical GmbHneon-yellow2023-10-18
EPRCA0034301otosil protect 50 I MSI pro3dure medical GmbHneon-orange2023-10-18
EPRCA0034302otosil protect 50 I MSI pro3dure medical GmbHneon-pink2023-10-18
EPRCA1001510audioprint GR-11.1pro3dure medical GmbH1kg - clear transparent2023-10-18
EPRCA1001511audioprint GR-11.1pro3dure medical GmbH1kg - black2023-10-18
EPRCA1001512audioprint GR-11.1pro3dure medical GmbH1kg - light-brown2023-10-18
EPRCA1001513audioprint GR-11.1pro3dure medical GmbH1kg - beige2023-10-18
EPRCA1001514audioprint GR-11.1pro3dure medical GmbH1kg - blue2023-10-18
EPRCA1001515audioprint GR-11.1pro3dure medical GmbH1kg - red2023-10-18
EPRCA1001516audioprint GR-11.1pro3dure medical GmbH1kg - white2023-10-18
EPRCA1001520audioprint GR-11.1 I MSIpro3dure medical GmbH1kg - beige2023-10-18
EPRCA1040440audioprint L-1 I MSI pro3dure medical GmbH50 g - Clear Transparent 2023-10-18
EPRCA1040441audioprint L-1 I MSI pro3dure medical GmbH100 g - Clear Transparent 2023-10-18
EPRCA4020229audioprint L-2 FLXpro3dure medical GmbH100 g - Clear Transparent 2023-10-18
EPRCA4020230audioprint L-2 FLX I MSIpro3dure medical GmbH100 g - Clear Transparent 2023-10-18
EPRCA1000294audioprint INR-1pro3dure medical GmbH1000 g bottle ; PurpleOpaque2023-10-16
EPRCA1000295audioprint INR-1pro3dure medical GmbH1000 g bottle ; Blue Opaque2023-10-16
EPRCA1000298audioprint INR-1pro3dure medical GmbH1000 g bottle ; Pink Opaque2023-10-16
E23942511Biopor® UV-SDreve Otoplastik GmbH42512023-10-11
EDET024271bioplast 60 shore rose 8 x 50mlDETAX GmbH024272023-07-04
EDET039221detax softwear 2.0 colormix 8 x 50 ml DETAX GmbH039222023-06-30
E239249551FotoTec® DLP.ADreve Otoplastik GmbH249552023-06-23
00810068831597Lucid®HEARING LAB TECHNOLOGY, LLCCustom RIC Sleeve2023-06-16
00812944021351Lucid®HEARING LAB TECHNOLOGY, LLCCustom Earmold2023-06-16
EDET032821addtion spectra standard pack Auto2DETAX GmbH032822023-02-03
EDET038881earflex 25 shore blue 8x50mlDETAX GmbH038882023-02-03
EDET038891earflex 25 shore red 8x50mlDETAX GmbH038892023-02-03