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Helix

EUDAMED

Class IIa (EU MDR)

Ref 137-024501120Model BTE Hearing Aids SeriesRef 137-024501119Ref 137-02450173Ref 137-024501121Ref 138-024601119Ref 138-024601120Ref 138-024601121Ref 141-02360192Model ITEKIT Hearing Aids SeriesRef 138-02460173Ref 134-02340192Ref 134-02340136Ref 142-02350171Model ITE Hearing Aids SeriesRef 144-02380136Ref 149-024301121Ref 143-02370180Ref 133-02330180Ref 143-02370171Ref 140-024801121Ref 150-02440173Ref 146-02400101Ref 138-02460192Ref 133-02330170Ref 142-02350192Ref 141-02360136Ref 150-024401120Ref 133-02330164Ref 146-02400171Ref 144-02380173Ref 150-024401121Ref 141-02360101Ref 105-02100138Ref 134-02340164Ref 150-0214401119Ref 132-023101108Model TIE Hearing Aids SeriesRef 140-02480173Ref 105-02100141Ref 141-02360173Ref 141-02360171Ref 139-02470173Ref 141-02360163Ref 147-024101121Ref 140-024801119Ref 146-02400163Ref 149-02430173Ref 132-02310190Ref 134-02340186Ref 128-022901107Ref 145-02390180Ref 132-023101107Ref 105-02100119Ref 145-02390163Ref 134-02340171Ref 143-02370163Ref 144-02380171Ref 141-02360186Ref 140-02480192Ref 128-02290190Ref 139-024701121Ref 147-024101120Ref 131-02300171Ref 144-02380164Ref 148-024201121Ref 140-024801120Ref 145-02390186Ref 134-02340101Ref 133-02330186Ref 139-02470192Ref 128-022901106Ref 137-02450192Ref 143-02370170Ref 137-02450163Ref 134-02340180Ref 141-02360170Ref 139-024701119Ref 144-02380101Ref 148-024201120Ref 105-02100179Ref 133-02330171Ref 134-02340173Ref 143-02370101Ref 133-02330136Ref 138-02460163Ref 142-02350163Ref 142-02350101Ref 132-02310191Ref 147-02410173Ref 141-02360180Ref 133-02330192Ref 148-02420173Ref 149-024301119Ref 139-02470163Ref 147-024101119Ref 146-02400180Ref 149-024301120Ref 133-02330173Ref 139-024701120Ref 105-02100178Ref 132-02310189Ref 144-02380192Ref 148-024201119Ref 143-02370192Ref 105-02100121Ref 134-02340170Ref 132-02310188Ref 133-02330101Ref 128-02290189Ref 145-02390171Ref 142-02350186Ref 105-02100144Ref 142-02350180Ref 132-023101106Ref 133-02330163Ref 134-02340163Ref 140-02480163Ref 142-02350164Ref 142-02350136Ref 145-02390192

by Ear Technic Hearing Aids

Identity

Trade Name
Helix EUDAMED
Device Name
BTE Family EUDAMED
ITEKIT Family EUDAMED
ITE Family EUDAMED
TIE Family EUDAMED
Model / Reference
BTE Hearing Aids Series EUDAMED
137-024501120 EUDAMED
137-024501119 EUDAMED
137-02450173 EUDAMED
137-024501121 EUDAMED
138-024601119 EUDAMED
138-024601120 EUDAMED
138-024601121 EUDAMED
ITEKIT Hearing Aids Series EUDAMED
141-02360192 EUDAMED
138-02460173 EUDAMED
134-02340192 EUDAMED
134-02340136 EUDAMED
ITE Hearing Aids Series EUDAMED
142-02350171 EUDAMED
144-02380136 EUDAMED
149-024301121 EUDAMED
143-02370180 EUDAMED
133-02330180 EUDAMED
143-02370171 EUDAMED
140-024801121 EUDAMED
150-02440173 EUDAMED
146-02400101 EUDAMED
138-02460192 EUDAMED
133-02330170 EUDAMED
142-02350192 EUDAMED
141-02360136 EUDAMED
150-024401120 EUDAMED
133-02330164 EUDAMED
146-02400171 EUDAMED
144-02380173 EUDAMED
150-024401121 EUDAMED
141-02360101 EUDAMED
105-02100138 EUDAMED
134-02340164 EUDAMED
150-0214401119 EUDAMED
TIE Hearing Aids Series EUDAMED
132-023101108 EUDAMED
140-02480173 EUDAMED
105-02100141 EUDAMED
141-02360173 EUDAMED
141-02360171 EUDAMED
139-02470173 EUDAMED
141-02360163 EUDAMED
147-024101121 EUDAMED
140-024801119 EUDAMED
146-02400163 EUDAMED
149-02430173 EUDAMED
132-02310190 EUDAMED
134-02340186 EUDAMED
128-022901107 EUDAMED
145-02390180 EUDAMED
132-023101107 EUDAMED
105-02100119 EUDAMED
145-02390163 EUDAMED
134-02340171 EUDAMED
143-02370163 EUDAMED
144-02380171 EUDAMED
141-02360186 EUDAMED
140-02480192 EUDAMED
128-02290190 EUDAMED
139-024701121 EUDAMED
147-024101120 EUDAMED
131-02300171 EUDAMED
144-02380164 EUDAMED
148-024201121 EUDAMED
140-024801120 EUDAMED
145-02390186 EUDAMED
134-02340101 EUDAMED
133-02330186 EUDAMED
139-02470192 EUDAMED
128-022901106 EUDAMED
137-02450192 EUDAMED
143-02370170 EUDAMED
137-02450163 EUDAMED
134-02340180 EUDAMED
141-02360170 EUDAMED
139-024701119 EUDAMED
144-02380101 EUDAMED
148-024201120 EUDAMED
105-02100179 EUDAMED
133-02330171 EUDAMED
134-02340173 EUDAMED
143-02370101 EUDAMED
133-02330136 EUDAMED
138-02460163 EUDAMED
142-02350163 EUDAMED
142-02350101 EUDAMED
132-02310191 EUDAMED
147-02410173 EUDAMED
141-02360180 EUDAMED
133-02330192 EUDAMED
148-02420173 EUDAMED
149-024301119 EUDAMED
139-02470163 EUDAMED
147-024101119 EUDAMED
146-02400180 EUDAMED
149-024301120 EUDAMED
133-02330173 EUDAMED
139-024701120 EUDAMED
105-02100178 EUDAMED
132-02310189 EUDAMED
144-02380192 EUDAMED
148-024201119 EUDAMED
143-02370192 EUDAMED
105-02100121 EUDAMED
134-02340170 EUDAMED
132-02310188 EUDAMED
133-02330101 EUDAMED
128-02290189 EUDAMED
145-02390171 EUDAMED
142-02350186 EUDAMED
105-02100144 EUDAMED
142-02350180 EUDAMED
132-023101106 EUDAMED
133-02330163 EUDAMED
134-02340163 EUDAMED
140-02480163 EUDAMED
142-02350164 EUDAMED
142-02350136 EUDAMED
145-02390192 EUDAMED

Identifiers

Primary DI / UDI-DI
08683873084876 EUDAMED
08683873088584 EUDAMED
08682549130473 EUDAMED
08683873082742 EUDAMED
08683873088607 EUDAMED
08683873088614 EUDAMED
08683873088591 EUDAMED
08683873084951 EUDAMED
08683873082797 EUDAMED
08683873084937 EUDAMED
08683873082773 EUDAMED
08682549132231 EUDAMED
08683873082704 EUDAMED
08683873084272 EUDAMED
08683873088546 EUDAMED
08682549130831 EUDAMED
08683873080830 EUDAMED
08682549130695 EUDAMED
08683873082834 EUDAMED
08683873080144 EUDAMED
08682549131623 EUDAMED
08683873085507 EUDAMED
08683873083374 EUDAMED
08682549130541 EUDAMED
08682549130640 EUDAMED
08682549132439 EUDAMED
08683873084302 EUDAMED
08683873083381 EUDAMED
08682549132422 EUDAMED
08682549134372 EUDAMED
08682549131432 EUDAMED
08683873082575 EUDAMED
08682549131531 EUDAMED
08682549130763 EUDAMED
08685149750621 EUDAMED
08683873085231 EUDAMED
08683873082926 EUDAMED
08683873080199 EUDAMED
08682549131135 EUDAMED
08683873085576 EUDAMED
08683873083459 EUDAMED
08683873084142 EUDAMED
08698666474543 EUDAMED
08683873080670 EUDAMED
08683873088898 EUDAMED
08682549131876 EUDAMED
08682549130503 EUDAMED
08698666474000 EUDAMED
08682549132774 EUDAMED
08682549131678 EUDAMED
08683873083404 EUDAMED
08682549131241 EUDAMED
08682549132255 EUDAMED
08682549130855 EUDAMED
08683873083183 EUDAMED
08683873088713 EUDAMED
08682549131098 EUDAMED
08682549132958 EUDAMED
08683873083190 EUDAMED
08682549130459 EUDAMED
08682549131609 EUDAMED
08682549131821 EUDAMED
08682549130916 EUDAMED
08682549131869 EUDAMED
08698666478077 EUDAMED
08682549131043 EUDAMED
08682549132590 EUDAMED
08682549130923 EUDAMED
08682549130602 EUDAMED
08682549131708 EUDAMED
08683873088935 EUDAMED
08683873082643 EUDAMED
08683873082940 EUDAMED
08682549130411 EUDAMED
08683873084296 EUDAMED
08683873084166 EUDAMED
08683873084159 EUDAMED
08683873085095 EUDAMED
08682549130367 EUDAMED
08683873085637 EUDAMED
08683873083312 EUDAMED
08683873085033 EUDAMED
08682549131036 EUDAMED
08682549131197 EUDAMED
08683873081288 EUDAMED
08682549131548 EUDAMED
08683873082599 EUDAMED
08682549131814 EUDAMED
08682549131302 EUDAMED
08683873082513 EUDAMED
08682549130534 EUDAMED
08685149750256 EUDAMED
08683873085521 EUDAMED
08683873080366 EUDAMED
08682549131685 EUDAMED
08683873088676 EUDAMED
08683873080588 EUDAMED
08682549131067 EUDAMED
08682549131357 EUDAMED
08683873082896 EUDAMED
08683873085163 EUDAMED
08683873085255 EUDAMED
08698666477988 EUDAMED
08682549132323 EUDAMED
08682549132552 EUDAMED
08682549131524 EUDAMED
08683873085224 EUDAMED
08682549130893 EUDAMED
08683873083350 EUDAMED
08682549130626 EUDAMED
08683873085026 EUDAMED
08683873084319 EUDAMED
08685149750324 EUDAMED
08682549131265 EUDAMED
08683873082827 EUDAMED
08683873080847 EUDAMED
08682549130947 EUDAMED
08683873082964 EUDAMED
08682549130985 EUDAMED
08682549131234 EUDAMED
08683873089222 EUDAMED
08683873085156 EUDAMED
08682549130466 EUDAMED
08682549130862 EUDAMED
08683873083268 EUDAMED
08683873083435 EUDAMED
08683873088669 EUDAMED
08682549131661 EUDAMED
08682549132637 EUDAMED
08682549130886 EUDAMED
08683873083213 EUDAMED
08682549131166 EUDAMED
08682549131272 EUDAMED
08683873082636 EUDAMED
08683873088706 EUDAMED
08682549132941 EUDAMED
08683873084326 EUDAMED
08683873088881 EUDAMED
08683873085064 EUDAMED
08682549132934 EUDAMED
08682549131289 EUDAMED
08685149750331 EUDAMED
08683873088775 EUDAMED
08683873085538 EUDAMED
08683873085187 EUDAMED
08682549132675 EUDAMED
08683873085170 EUDAMED
08683873083442 EUDAMED
08683873083251 EUDAMED
08683873084982 EUDAMED
08698666477742 EUDAMED
08683873085019 EUDAMED
08682549131319 EUDAMED
08683873085125 EUDAMED
08682549130633 EUDAMED
08683873081530 EUDAMED
08683873082582 EUDAMED
08685149750287 EUDAMED
08682549132644 EUDAMED
08683873082919 EUDAMED
08682549131364 EUDAMED
08683873082902 EUDAMED
08682549131562 EUDAMED
08683873088799 EUDAMED
08683873088836 EUDAMED
08683873088744 EUDAMED
08682549132576 EUDAMED
08683873085217 EUDAMED
08683873082810 EUDAMED
08682549132224 EUDAMED
08682549131326 EUDAMED
08698666477926 EUDAMED
08683873081523 EUDAMED
08682549130688 EUDAMED
08683873084975 EUDAMED
08682549131142 EUDAMED
08683873083367 EUDAMED
08682549131586 EUDAMED
08682549130435 EUDAMED
08682549130589 EUDAMED
08683873082605 EUDAMED
08682549132569 EUDAMED
08682549130770 EUDAMED
08682549131647 EUDAMED
08685149750300 EUDAMED
08698666473966 EUDAMED
08683873083282 EUDAMED
08683873083220 EUDAMED
08683873088683 EUDAMED
08682549130817 EUDAMED
08683873085248 EUDAMED
08683873082889 EUDAMED
08683873086115 EUDAMED
08683873088805 EUDAMED
08683873082872 EUDAMED
08682549131180 EUDAMED
08682549131227 EUDAMED
08685149750362 EUDAMED
08683873080687 EUDAMED
08683873089185 EUDAMED
08682549131425 EUDAMED
08683873084340 EUDAMED
08683873088119 EUDAMED
08685149750317 EUDAMED
08683873085002 EUDAMED
08685149750379 EUDAMED
08682549131852 EUDAMED
08682549130961 EUDAMED
08682549131401 EUDAMED
08683873085118 EUDAMED
08683873080441 EUDAMED
Basic UDI-DI
B-08683873084876 EUDAMED
B-08683873088584 EUDAMED
B-08682549130473 EUDAMED
B-08683873082742 EUDAMED
B-08683873088607 EUDAMED
B-08683873088614 EUDAMED
B-08683873088591 EUDAMED
B-08683873084951 EUDAMED
B-08683873082797 EUDAMED
B-08683873084937 EUDAMED
B-08683873082773 EUDAMED
B-08682549132231 EUDAMED
B-08683873082704 EUDAMED
B-08683873084272 EUDAMED
B-08683873088546 EUDAMED
B-08682549130831 EUDAMED
B-08683873080830 EUDAMED
B-08682549130695 EUDAMED
B-08683873082834 EUDAMED
B-08683873080144 EUDAMED
B-08682549131623 EUDAMED
B-08683873085507 EUDAMED
B-08683873083374 EUDAMED
B-08682549130541 EUDAMED
B-08682549130640 EUDAMED
B-08682549132439 EUDAMED
B-08683873084302 EUDAMED
B-08683873083381 EUDAMED
B-08682549132422 EUDAMED
B-08682549134372 EUDAMED
B-08682549131432 EUDAMED
B-08683873082575 EUDAMED
B-08682549131531 EUDAMED
B-08682549130763 EUDAMED
B-08685149750621 EUDAMED
B-08683873085231 EUDAMED
B-08683873082926 EUDAMED
B-08683873080199 EUDAMED
B-08682549131135 EUDAMED
B-08683873085576 EUDAMED
B-08683873083459 EUDAMED
B-08683873084142 EUDAMED
B-08698666474543 EUDAMED
B-08683873080670 EUDAMED
B-08683873088898 EUDAMED
B-08682549131876 EUDAMED
B-08682549130503 EUDAMED
B-08698666474000 EUDAMED
B-08682549132774 EUDAMED
B-08682549131678 EUDAMED
B-08683873083404 EUDAMED
B-08682549131241 EUDAMED
B-08682549132255 EUDAMED
B-08682549130855 EUDAMED
B-08683873083183 EUDAMED
B-08683873088713 EUDAMED
B-08682549131098 EUDAMED
B-08682549132958 EUDAMED
B-08683873083190 EUDAMED
B-08682549130459 EUDAMED
B-08682549131609 EUDAMED
B-08682549131821 EUDAMED
B-08682549130916 EUDAMED
B-08682549131869 EUDAMED
B-08698666478077 EUDAMED
B-08682549131043 EUDAMED
B-08682549132590 EUDAMED
B-08682549130923 EUDAMED
B-08682549130602 EUDAMED
B-08682549131708 EUDAMED
B-08683873088935 EUDAMED
B-08683873082643 EUDAMED
B-08683873082940 EUDAMED
B-08682549130411 EUDAMED
B-08683873084296 EUDAMED
B-08683873084166 EUDAMED
B-08683873084159 EUDAMED
B-08683873085095 EUDAMED
B-08682549130367 EUDAMED
B-08683873085637 EUDAMED
B-08683873083312 EUDAMED
B-08683873085033 EUDAMED
B-08682549131036 EUDAMED
B-08682549131197 EUDAMED
B-08683873081288 EUDAMED
B-08682549131548 EUDAMED
B-08683873082599 EUDAMED
B-08682549131814 EUDAMED
B-08682549131302 EUDAMED
B-08683873082513 EUDAMED
B-08682549130534 EUDAMED
B-08685149750256 EUDAMED
B-08683873085521 EUDAMED
B-08683873080366 EUDAMED
B-08682549131685 EUDAMED
B-08683873088676 EUDAMED
B-08683873080588 EUDAMED
B-08682549131067 EUDAMED
B-08682549131357 EUDAMED
B-08683873082896 EUDAMED
B-08683873085163 EUDAMED
B-08683873085255 EUDAMED
B-08698666477988 EUDAMED
B-08682549132323 EUDAMED
B-08682549132552 EUDAMED
B-08682549131524 EUDAMED
B-08683873085224 EUDAMED
B-08682549130893 EUDAMED
B-08683873083350 EUDAMED
B-08682549130626 EUDAMED
B-08683873085026 EUDAMED
B-08683873084319 EUDAMED
B-08685149750324 EUDAMED
B-08682549131265 EUDAMED
B-08683873082827 EUDAMED
B-08683873080847 EUDAMED
B-08682549130947 EUDAMED
B-08683873082964 EUDAMED
B-08682549130985 EUDAMED
B-08682549131234 EUDAMED
B-08683873089222 EUDAMED
B-08683873085156 EUDAMED
B-08682549130466 EUDAMED
B-08682549130862 EUDAMED
B-08683873083268 EUDAMED
B-08683873083435 EUDAMED
B-08683873088669 EUDAMED
B-08682549131661 EUDAMED
B-08682549132637 EUDAMED
B-08682549130886 EUDAMED
B-08683873083213 EUDAMED
B-08682549131166 EUDAMED
B-08682549131272 EUDAMED
B-08683873082636 EUDAMED
B-08683873088706 EUDAMED
B-08682549132941 EUDAMED
B-08683873084326 EUDAMED
B-08683873088881 EUDAMED
B-08683873085064 EUDAMED
B-08682549132934 EUDAMED
B-08682549131289 EUDAMED
B-08685149750331 EUDAMED
B-08683873088775 EUDAMED
B-08683873085538 EUDAMED
B-08683873085187 EUDAMED
B-08682549132675 EUDAMED
B-08683873085170 EUDAMED
B-08683873083442 EUDAMED
B-08683873083251 EUDAMED
B-08683873084982 EUDAMED
B-08698666477742 EUDAMED
B-08683873085019 EUDAMED
B-08682549131319 EUDAMED
B-08683873085125 EUDAMED
B-08682549130633 EUDAMED
B-08683873081530 EUDAMED
B-08683873082582 EUDAMED
B-08685149750287 EUDAMED
B-08682549132644 EUDAMED
B-08683873082919 EUDAMED
B-08682549131364 EUDAMED
B-08683873082902 EUDAMED
B-08682549131562 EUDAMED
B-08683873088799 EUDAMED
B-08683873088836 EUDAMED
B-08683873088744 EUDAMED
B-08682549132576 EUDAMED
B-08683873085217 EUDAMED
B-08683873082810 EUDAMED
B-08682549132224 EUDAMED
B-08682549131326 EUDAMED
B-08698666477926 EUDAMED
B-08683873081523 EUDAMED
B-08682549130688 EUDAMED
B-08683873084975 EUDAMED
B-08682549131142 EUDAMED
B-08683873083367 EUDAMED
B-08682549131586 EUDAMED
B-08682549130435 EUDAMED
B-08682549130589 EUDAMED
B-08683873082605 EUDAMED
B-08682549132569 EUDAMED
B-08682549130770 EUDAMED
B-08682549131647 EUDAMED
B-08685149750300 EUDAMED
B-08698666473966 EUDAMED
B-08683873083282 EUDAMED
B-08683873083220 EUDAMED
B-08683873088683 EUDAMED
B-08682549130817 EUDAMED
B-08683873085248 EUDAMED
B-08683873082889 EUDAMED
B-08683873086115 EUDAMED
B-08683873088805 EUDAMED
B-08683873082872 EUDAMED
B-08682549131180 EUDAMED
B-08682549131227 EUDAMED
B-08685149750362 EUDAMED
B-08683873080687 EUDAMED
B-08683873089185 EUDAMED
B-08682549131425 EUDAMED
B-08683873084340 EUDAMED
B-08683873088119 EUDAMED
B-08685149750317 EUDAMED
B-08683873085002 EUDAMED
B-08685149750379 EUDAMED
B-08682549131852 EUDAMED
B-08682549130961 EUDAMED
B-08682549131401 EUDAMED
B-08683873085118 EUDAMED
B-08683873080441 EUDAMED
EMDN Code
Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) EUDAMED
Y2145060101 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE) EUDAMED
Y2145060203 HEARING AIDS COMPLETELY-IN-THE-CANAL (CIC) EUDAMED
Y21450603 BOX HEARING AIDS EUDAMED
Y2145060202 HEARING AIDS IN-THE-CANAL (ITC) EUDAMED
Y2145060201 HEARING AID IN THE-EAR (ITE) EUDAMED
Y2145060204 HEARING AIDS INVISIBLE-IN-THE-CANAL (IIC) EUDAMED

Classification

Device Class
Class IIa EUDAMED
Class III EUDAMED
Market of Registration
Türkiye EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMEDEUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMEDEUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Category: Air-conduction hearing aid, receiver-in-canal

Helix by Ear Technic Hearing Aids — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Similar devices

Also classified as Air-conduction hearing aid, receiver-in-canal.

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Ear Technic Hearing Aids
EUDAMED SRN
TR-MF-000034630

Sources (211)

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