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Oticon

EUDAMEDFDA UDI

Class IIa (EU MDR)

Ref 245682Model HI (ITE)Ref 240950Model HI (BTE)Ref 234419Ref 289420Ref 245684Ref 283390Ref 285636Ref 279493Ref 290632Ref 248148Ref 235961Ref 228970Ref 283389Ref 283387Ref 250647Ref 251803Ref 292713Ref 232082Model CROS/BI-CROS transmitterRef 289473Ref 285635Ref 234150Ref 276952Ref 271282Ref 234916Ref 276949Ref 279494Ref 290606Ref 229951Ref 292686Ref 255709Model Hearing instrument chargerRef 245696Ref 290598Ref 271284Ref 238300Ref 289492Ref 269806Ref 279276Ref 245686Ref 248149Ref 291855Ref 279522Ref 289496Ref 245702Ref 245690Ref 245699Ref 238298Ref 258710Ref 283391Ref 279516Ref 289490Ref 255703Ref 290596Ref 290617Ref 229958Ref 276480Ref 245700Ref 289478Ref 271277Ref 228969Ref 276703Ref 286086Model OneAppRef 289415Ref 234823Ref 241191Ref 231819Ref 289421Ref 229045Ref 290615Ref 241056Ref 279964Ref 241055Ref 289423Ref 256122Ref 279508Ref 275798Ref 287647Ref 289436Ref 269801Ref 276373Ref 291817Ref 234421Ref 289405Ref 234414Ref 291820Ref 289909Ref 292693Ref 276947Ref 248577Ref 248576Ref 271281Ref 251797Ref 276954Ref 269622Ref 290616Ref 279966Ref 291842Ref 289480Ref 269805Ref 289484Ref 291850Ref 279515Ref 291847Ref 240603Ref 251799Ref 289476Ref 291819Ref 290594Ref 291856Ref 283384Ref 289449Ref 258706Ref 269804Ref 291897Ref 279501Ref 289451Ref 236457Ref 234423Ref 289400Ref 279502Ref 235957Ref 276591Ref 282113Ref 292687Ref 279497Ref 248146Ref 291854Ref 289499Ref 257259Ref 234831Ref 238303Ref 245681Ref 250837Ref 283388Ref 265986Ref 257262Ref 289497Ref 228975Ref 248312Ref 235962Ref 279282Ref 245705Ref 127837Model Phone AdapterRef 235958Ref 276483Ref 248151Ref 289483Ref 229949Ref 232085Ref 276700Ref 289481Ref 257263Ref 279958Ref 291846Ref 275797Ref 248669Ref 229948Ref 291858Ref 232080Ref 271279Ref 279498Ref 229047Ref 289408Ref 276701Ref 292671Ref 235959Ref 290609Ref 291851Ref 248668Ref 292682Ref 289454Ref 292678Ref 250513Ref 229953Ref 245691Ref 279965Ref 228740Ref 289446Ref 289489Ref 229950Ref 245695Ref 245703Ref 229044Ref 289915Ref 258708Ref 290625Ref 276951Ref 250442Ref 289407Ref 285019Ref 248573Ref 250516Ref 292694Ref 283392Ref 231817Ref 240951Ref 283386Ref 291843Ref 292672Ref 279278Ref 245694Ref 259731Ref 292715Ref 289402Ref 289465Ref 276371Ref 289466Ref 231820Ref 291845Ref 289477Ref 228974Ref 289470Ref 291860Ref 290597Ref 291848Ref 279495Ref 289417Ref 289447Ref 279963Ref 290599Ref 279281Ref 235963Ref 276482Ref 292690Ref 289404Ref 250649Ref 289448Ref 279960Ref 289453Ref 276953Ref 289912Ref 259730Ref 234417Ref 258709Ref 289403Ref 289498Ref 235955Ref 251801Ref 289432Ref 230022Ref 289431Ref 229046Ref 279500Ref 289406Ref 289485Ref 228968Ref 289464Ref 234420Ref 276372Ref 250439Ref 245688Ref 290621Ref 289482Ref 250648Ref 289911Ref 269623Ref 289461Ref 245685Ref 292695Ref 279499Ref 235956Ref 245689

by SBO Hearing A/S

Identity

Trade Name
Oticon EUDAMEDFDA UDI
Generic Name
Air-conduction hearing aid, behind-the-ear FDA UDI
Device Name
OTICON OPN S 3 BTE PP C044 FDA UDI
Model / Reference
HI (ITE) EUDAMED
245682 EUDAMED
HI (BTE) EUDAMED
240950 EUDAMED
234419 EUDAMED
289420 EUDAMED
245684 EUDAMED
283390 EUDAMED
285636 EUDAMED
279493 EUDAMED
290632 EUDAMED
248148 EUDAMED
235961 EUDAMED
228970 EUDAMED
283389 EUDAMED
283387 EUDAMED
250647 EUDAMED
251803 EUDAMED
292713 EUDAMED
CROS/BI-CROS transmitter EUDAMED
232082 EUDAMED
289473 EUDAMED
285635 EUDAMED
234150 EUDAMED
276952 EUDAMED
271282 EUDAMED
234916 EUDAMED
276949 EUDAMED
279494 EUDAMED
290606 EUDAMED
229951 EUDAMED
292686 EUDAMED
Hearing instrument charger EUDAMED
255709 EUDAMED
245696 EUDAMED
290598 EUDAMED
271284 EUDAMED
238300 EUDAMED
289492 EUDAMED
269806 EUDAMED
279276 EUDAMED
245686 EUDAMED
248149 EUDAMED
291855 EUDAMED
279522 EUDAMED
289496 EUDAMED
245702 EUDAMED
245690 EUDAMED
245699 EUDAMED
238298 EUDAMED
258710 EUDAMED
283391 EUDAMED
279516 EUDAMED
289490 EUDAMED
255703 EUDAMED
290596 EUDAMED
290617 EUDAMED
229958 EUDAMED
276480 EUDAMED
245700 EUDAMED
289478 EUDAMED
271277 EUDAMED
228969 EUDAMED
276703 EUDAMED
OneApp EUDAMED
286086 EUDAMED
289415 EUDAMED
234823 EUDAMED
241191 EUDAMED
231819 EUDAMED
289421 EUDAMED
229045 EUDAMED
290615 EUDAMED
241056 EUDAMED
279964 EUDAMED
241055 EUDAMED
289423 EUDAMED
256122 EUDAMED
279508 EUDAMED
275798 EUDAMED
287647 EUDAMED
289436 EUDAMED
269801 EUDAMED
276373 EUDAMED
291817 EUDAMED
234421 EUDAMED
289405 EUDAMED
234414 EUDAMED
291820 EUDAMED
289909 EUDAMED
292693 EUDAMED
276947 EUDAMED
248577 EUDAMED
248576 EUDAMED
271281 EUDAMED
251797 EUDAMED
276954 EUDAMED
269622 EUDAMED
290616 EUDAMED
279966 EUDAMED
291842 EUDAMED
289480 EUDAMED
269805 EUDAMED
289484 EUDAMED
291850 EUDAMED
279515 EUDAMED
291847 EUDAMED
240603 EUDAMED
251799 EUDAMED
289476 EUDAMED
291819 EUDAMED
290594 EUDAMED
291856 EUDAMED
283384 EUDAMED
289449 EUDAMED
258706 EUDAMED
269804 EUDAMED
291897 EUDAMED
279501 EUDAMED
289451 EUDAMED
236457 EUDAMED
234423 EUDAMED
289400 EUDAMED
279502 EUDAMED
235957 EUDAMED
276591 EUDAMED
282113 EUDAMED
292687 EUDAMED
279497 EUDAMED
248146 EUDAMED
291854 EUDAMED
289499 EUDAMED
257259 EUDAMED
234831 EUDAMED
238303 EUDAMED
245681 EUDAMED
250837 EUDAMED
283388 EUDAMED
265986 EUDAMED
257262 EUDAMED
289497 EUDAMED
228975 EUDAMED
248312 EUDAMED
235962 EUDAMED
279282 EUDAMED
245705 EUDAMED
Phone Adapter EUDAMED
127837 EUDAMED
235958 EUDAMED
276483 EUDAMED
248151 EUDAMED
289483 EUDAMED
229949 EUDAMED
232085 EUDAMED
276700 EUDAMED
289481 EUDAMED
257263 EUDAMED
279958 EUDAMED
291846 EUDAMED
275797 EUDAMED
248669 EUDAMED
229948 EUDAMED
291858 EUDAMED
232080 EUDAMED
271279 EUDAMED
279498 EUDAMED
229047 EUDAMED
289408 EUDAMED
276701 EUDAMED
292671 EUDAMED
235959 EUDAMED
290609 EUDAMED
291851 EUDAMED
248668 EUDAMED
292682 EUDAMED
289454 EUDAMED
292678 EUDAMED
250513 EUDAMED
229953 EUDAMED
245691 EUDAMED
279965 EUDAMED
228740 EUDAMEDFDA UDI
289446 EUDAMED
289489 EUDAMED
229950 EUDAMED
245695 EUDAMED
245703 EUDAMED
229044 EUDAMED
289915 EUDAMED
258708 EUDAMED
290625 EUDAMED
276951 EUDAMED
250442 EUDAMED
289407 EUDAMED
285019 EUDAMED
248573 EUDAMED
250516 EUDAMED
292694 EUDAMED
283392 EUDAMED
231817 EUDAMED
240951 EUDAMED
283386 EUDAMED
291843 EUDAMED
292672 EUDAMED
279278 EUDAMED
245694 EUDAMED
259731 EUDAMED
292715 EUDAMED
289402 EUDAMED
289465 EUDAMED
276371 EUDAMED
289466 EUDAMED
231820 EUDAMED
291845 EUDAMED
289477 EUDAMED
228974 EUDAMED
289470 EUDAMED
291860 EUDAMED
290597 EUDAMED
291848 EUDAMED
279495 EUDAMED
289417 EUDAMED
289447 EUDAMED
279963 EUDAMED
290599 EUDAMED
279281 EUDAMED
235963 EUDAMED
276482 EUDAMED
292690 EUDAMED
289404 EUDAMED
250649 EUDAMED
289448 EUDAMED
279960 EUDAMED
289453 EUDAMED
276953 EUDAMED
289912 EUDAMED
259730 EUDAMED
234417 EUDAMED
258709 EUDAMED
289403 EUDAMED
289498 EUDAMED
235955 EUDAMED
251801 EUDAMED
289432 EUDAMED
230022 EUDAMED
289431 EUDAMED
229046 EUDAMED
279500 EUDAMED
289406 EUDAMED
289485 EUDAMED
228968 EUDAMED
289464 EUDAMED
234420 EUDAMED
276372 EUDAMED
250439 EUDAMED
245688 EUDAMED
290621 EUDAMED
289482 EUDAMED
250648 EUDAMED
289911 EUDAMED
269623 EUDAMED
289461 EUDAMED
245685 EUDAMED
292695 EUDAMED
279499 EUDAMED
235956 EUDAMED
245689 EUDAMED
Description
OTICON OPN S 3 BTE PP C044 FDA UDI

Identifiers

Primary DI / UDI-DI
05714464062126 EUDAMED
05714464055685 EUDAMED
05714464037469 EUDAMED
05714464182985 EUDAMED
05714464061846 EUDAMED
05714464170029 EUDAMED
05714464170869 EUDAMED
05714464171385 EUDAMED
05714464197187 EUDAMED
05714464067428 EUDAMED
05714464051595 EUDAMED
05714464014750 EUDAMED
05714464170012 EUDAMED
05714464169993 EUDAMED
05714464089628 EUDAMED
05714464088126 EUDAMED
05714464196555 EUDAMED
05714464033607 EUDAMED
05714464183395 EUDAMED
05714464170876 EUDAMED
05714464034789 EUDAMED
05714464159246 EUDAMED
05714464149278 EUDAMED
05714464042234 EUDAMED
05714464159215 EUDAMED
05714464171392 EUDAMED
05714464196937 EUDAMED
05714464023240 EUDAMED
05714464196289 EUDAMED
05714464099382 EUDAMED
05714464063772 EUDAMED
05714464196869 EUDAMED
05714464149292 EUDAMED
05714464113057 EUDAMED
05714464183586 EUDAMED
05714464136414 EUDAMED
05714464173259 EUDAMED
05714464062775 EUDAMED
05714464067435 EUDAMED
05714464194582 EUDAMED
05714464173624 EUDAMED
05714464183623 EUDAMED
05714464064151 EUDAMED
05714464062454 EUDAMED
05714464063390 EUDAMED
05714464112128 EUDAMED
05714464103805 EUDAMED
05714464170036 EUDAMED
05714464173563 EUDAMED
05714464183562 EUDAMED
05714464098873 EUDAMED
05714464196845 EUDAMED
05714464197033 EUDAMED
05714464024674 EUDAMED
05714464151981 EUDAMED
05714464063482 EUDAMED
05714464183449 EUDAMED
05714464149223 EUDAMED
05714464014255 EUDAMED
05714464155262 EUDAMED
05714464175611 EUDAMED
05714464182930 EUDAMED
05714464041350 EUDAMED
05714464055913 EUDAMED
05714464033317 EUDAMED
05714464182992 EUDAMED
05714464016204 EUDAMED
05714464197019 EUDAMED
05714464058174 EUDAMED
05714464173211 EUDAMED
05714464058167 EUDAMED
05714464183012 EUDAMED
05714464109920 EUDAMED
05714464173488 EUDAMED
05714464150557 EUDAMED
05714464177042 EUDAMED
05714464183098 EUDAMED
05714464136360 EUDAMED
05714464155590 EUDAMED
05714464194407 EUDAMED
05714464037483 EUDAMED
05714464182862 EUDAMED
05714464037414 EUDAMED
05714464194438 EUDAMED
05714464187188 EUDAMED
05714464196357 EUDAMED
05714464159192 EUDAMED
05714464076130 EUDAMED
05714464075782 EUDAMED
05714464149261 EUDAMED
05714464087921 EUDAMED
05714464159260 EUDAMED
05714464134199 EUDAMED
05714464197026 EUDAMED
05714464173235 EUDAMED
05714464194452 EUDAMED
05714464183463 EUDAMED
05714464136407 EUDAMED
05714464183500 EUDAMED
05714464194537 EUDAMED
05714464173556 EUDAMED
05714464194506 EUDAMED
05714464056620 EUDAMED
05714464087877 EUDAMED
05714464183425 EUDAMED
05714464194421 EUDAMED
05714464196821 EUDAMED
05714464194599 EUDAMED
05714464169962 EUDAMED
05714464183180 EUDAMED
05714464101580 EUDAMED
05714464136391 EUDAMED
05714464194841 EUDAMED
05714464173419 EUDAMED
05714464183203 EUDAMED
05714464050765 EUDAMED
05714464037506 EUDAMED
05714464182824 EUDAMED
05714464173426 EUDAMED
05714464046140 EUDAMED
05714464154999 EUDAMED
05714464164134 EUDAMED
05714464196296 EUDAMED
05714464171422 EUDAMED
05714464066995 EUDAMED
05714464194575 EUDAMED
05714464183654 EUDAMED
05714464118724 EUDAMED
05714464041435 EUDAMED
05714464114061 EUDAMED
05714464062256 EUDAMED
05714464092437 EUDAMED
05714464170005 EUDAMED
05714464131037 EUDAMED
05714464119332 EUDAMED
05714464183630 EUDAMED
05714464015832 EUDAMED
05714464068302 EUDAMED
05714464046164 EUDAMED
05714464173310 EUDAMED
05714464063963 EUDAMED
05707131250827 EUDAMED
05714464051571 EUDAMED
05714464152018 EUDAMED
05714464067794 EUDAMED
05714464183494 EUDAMED
05714464022731 EUDAMED
05714464033638 EUDAMED
05714464155699 EUDAMED
05714464183470 EUDAMED
05714464119899 EUDAMED
05714464173150 EUDAMED
05714464194490 EUDAMED
05714464150724 EUDAMED
05714464077281 EUDAMED
05714464022724 EUDAMED
05714464194612 EUDAMED
05714464033584 EUDAMED
05714464149247 EUDAMED
05714464171439 EUDAMED
05714464016921 EUDAMED
05714464182893 EUDAMED
05714464155705 EUDAMED
05714464196135 EUDAMED
05714464051588 EUDAMED
05714464196968 EUDAMED
05714464194544 EUDAMED
05714464076659 EUDAMED
05714464196241 EUDAMED
05714464183234 EUDAMED
05714464196203 EUDAMED
05714464090228 EUDAMED
05714464023844 EUDAMED
05714464063291 EUDAMED
05714464173228 EUDAMED
05714464014811 EUDAMEDFDA UDI
05714464183159 EUDAMED
05714464183555 EUDAMED
05714464023233 EUDAMED
05714464062973 EUDAMED
05714464064052 EUDAMED
05714464016198 EUDAMED
05714464187249 EUDAMED
05714464102709 EUDAMED
05714464197118 EUDAMED
05714464159239 EUDAMED
05714464089475 EUDAMED
05714464182886 EUDAMED
05714464168026 EUDAMED
05714464075348 EUDAMED
05714464089451 EUDAMED
05714464196364 EUDAMED
05714464170043 EUDAMED
05714464033294 EUDAMED
05714464055692 EUDAMED
05714464169986 EUDAMED
05714464194469 EUDAMED
05714464196142 EUDAMED
05714464173273 EUDAMED
05714464062881 EUDAMED
05714464104352 EUDAMED
05714464196579 EUDAMED
05714464182831 EUDAMED
05714464183319 EUDAMED
05714464155576 EUDAMED
05714464183326 EUDAMED
05714464033324 EUDAMED
05714464194483 EUDAMED
05714464183432 EUDAMED
05714464015825 EUDAMED
05714464183364 EUDAMED
05714464194636 EUDAMED
05714464196852 EUDAMED
05714464194513 EUDAMED
05714464171408 EUDAMED
05714464182954 EUDAMED
05714464183166 EUDAMED
05714464173204 EUDAMED
05714464196876 EUDAMED
05714464173303 EUDAMED
05714464051601 EUDAMED
05714464152001 EUDAMED
05714464196326 EUDAMED
05714464182855 EUDAMED
05714464089659 EUDAMED
05714464183173 EUDAMED
05714464173174 EUDAMED
05714464183227 EUDAMED
05714464159253 EUDAMED
05714464187218 EUDAMED
05714464103263 EUDAMED
05714464037445 EUDAMED
05714464102716 EUDAMED
05714464182848 EUDAMED
05714464183647 EUDAMED
05714464046126 EUDAMED
05714464088348 EUDAMED
05714464183050 EUDAMED
05714464025053 EUDAMED
05714464183043 EUDAMED
05714464016914 EUDAMED
05714464171453 EUDAMED
05714464182879 EUDAMED
05714464183517 EUDAMED
05714464014248 EUDAMED
05714464183302 EUDAMED
05714464037476 EUDAMED
05714464155583 EUDAMED
05714464090495 EUDAMED
05714464062553 EUDAMED
05714464197071 EUDAMED
05714464183487 EUDAMED
05714464092710 EUDAMED
05714464187201 EUDAMED
05714464134205 EUDAMED
05714464183272 EUDAMED
05714464061938 EUDAMED
05714464196371 EUDAMED
05714464171446 EUDAMED
05714464046133 EUDAMED
05714464062362 EUDAMED
Basic UDI-DI
57144640-HI-00076-RW EUDAMED
57144640-HI-00052-R8 EUDAMED
57144640-HI-000014-WQ EUDAMED
57144640-HI-00081-RL EUDAMED
57144640-CROS-00068-L5 EUDAMED
57144640-HICHAR-00064-X4 EUDAMED
57144640-ONEAPP-00086-KM EUDAMED
57144640-HICHAR-00093-XG EUDAMED
57144640-HICHAR-00099-Y2 EUDAMED
57071313-PA-00003-KU EUDAMED
Direct Marketing DI
05714464173624 EUDAMED
05714464134199 EUDAMED
05714464173235 EUDAMED
05714464183654 EUDAMED
05714464183630 EUDAMED
05714464183234 EUDAMED
05714464170043 EUDAMED
05714464183647 EUDAMED
05714464134205 EUDAMED
FDA Product Code
OSM FDA UDI
EMDN Code
Y2145060203 HEARING AIDS COMPLETELY-IN-THE-CANAL (CIC) EUDAMED
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
Y2145060201 HEARING AID IN THE-EAR (ITE) EUDAMED
Y214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMED
Y2145060204 HEARING AIDS INVISIBLE-IN-THE-CANAL (IIC) EUDAMED
Y214599 HEARING AIDS - OTHER EUDAMED
Y2145060202 HEARING AIDS IN-THE-CANAL (ITC) EUDAMED
GMDN Term
Air-conduction hearing aid, behind-the-ear FDA UDI

Classification

Device Class
Class IIa EUDAMED
Class I EUDAMED
Class II FDA UDI
Regulation Number
874.3305 FDA UDI
Special Device Type
Software EUDAMED
Market of Registration
Denmark EUDAMED
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

EUDAMEDFDA UDI

Single Use

No

FDA UDI

Implantable

No

EUDAMEDFDA UDI

Reusable

No

EUDAMED

Contains Latex

No

EUDAMEDFDA UDI

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Oticon by Sbo Hearing A/S — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
SBO Hearing A/S
EUDAMED SRN
DK-MF-000001270

Sources (262)

  • EUDAMED 3b8eeb98-fbfe-45a5-a04a-333c8b227b14 61 fields · synced Sep 17, 2026
  • EUDAMED 4b293aaa-2851-4e6e-a660-4923f3ebbd9a 61 fields · synced May 11, 2026
  • EUDAMED 96917dcf-8a5e-4054-8e51-c77057ec2ff0 61 fields · synced May 11, 2026
  • EUDAMED c517a6df-4909-485f-9d69-028dc991125e 61 fields · synced May 11, 2026
  • EUDAMED fbe01ef0-4e0e-44a6-bc79-592dac1f0bbe 61 fields · synced May 11, 2026
  • EUDAMED 0b58ba63-097d-4d6c-af57-ddfc24152959 61 fields · synced May 11, 2026
  • EUDAMED 1816eaf8-0188-4ee1-ac14-711f4c9a057d 61 fields · synced May 11, 2026
  • EUDAMED 18df5637-1a29-41c6-a064-1bbc51b63188 61 fields · synced May 11, 2026
  • EUDAMED 1857188f-c9f7-45a6-a3c7-92af1adabd76 61 fields · synced May 11, 2026
  • EUDAMED 24cc0b5a-fbec-48d2-ad6f-a36954f67b17 61 fields · synced May 16, 2026
  • EUDAMED b6f25a2c-c001-4f55-b062-bdbfe14746cc 61 fields · synced May 16, 2026
  • EUDAMED 816d0dac-d525-45fe-a874-eafd03f785ba 61 fields · synced May 16, 2026
  • EUDAMED 8de88e35-d9b2-4724-8dcf-f7c14f671ccb 61 fields · synced May 16, 2026
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