← Back to catalogue
Audilab
EUDAMEDClass IIa (EU MDR)
Ref 230549Model HI (BTE)Ref 230548Ref 222147Ref 236096Ref 234548Ref 234556Ref 236109Ref 222149Ref 230543Ref 222148Ref 222143Ref 236103Ref 222151Ref 222140Ref 222150Ref 236108Ref 234540Ref 234549Ref 230552Ref 234550Ref 230556Ref 236094Ref 236101Ref 222146Ref 234559Ref 222155Ref 234555Ref 222139Ref 222156Ref 230546Ref 222154Ref 230550Ref 230559Ref 236102Ref 230555Ref 236099Ref 222157Ref 234547Ref 236093Ref 234545Ref 236107Ref 234541Ref 234558Ref 234557Ref 222158Ref 236105Ref 230544
Identity
- Trade Name
- Audilab EUDAMED
- Model / Reference
- HI (BTE) EUDAMED230549 EUDAMED230548 EUDAMED222147 EUDAMED236096 EUDAMED234548 EUDAMED234556 EUDAMED236109 EUDAMED222149 EUDAMED230543 EUDAMED222148 EUDAMED222143 EUDAMED236103 EUDAMED222151 EUDAMED222140 EUDAMED222150 EUDAMED236108 EUDAMED234540 EUDAMED234549 EUDAMED230552 EUDAMED234550 EUDAMED230556 EUDAMED236094 EUDAMED236101 EUDAMED222146 EUDAMED234559 EUDAMED222155 EUDAMED234555 EUDAMED222139 EUDAMED222156 EUDAMED230546 EUDAMED222154 EUDAMED230550 EUDAMED230559 EUDAMED236102 EUDAMED230555 EUDAMED236099 EUDAMED222157 EUDAMED234547 EUDAMED236093 EUDAMED234545 EUDAMED236107 EUDAMED234541 EUDAMED234558 EUDAMED234557 EUDAMED222158 EUDAMED236105 EUDAMED230544 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05714464031542 EUDAMED05714464031535 EUDAMED05714464009763 EUDAMED05714464047314 EUDAMED05714464038756 EUDAMED05714464038831 EUDAMED05714464047444 EUDAMED05714464009787 EUDAMED05714464031030 EUDAMED05714464009770 EUDAMED05714464009190 EUDAMED05714464047383 EUDAMED05714464009800 EUDAMED05714464009169 EUDAMED05714464009794 EUDAMED05714464047437 EUDAMED05714464038671 EUDAMED05714464038763 EUDAMED05714464031573 EUDAMED05714464038770 EUDAMED05714464032068 EUDAMED05714464047291 EUDAMED05714464047369 EUDAMED05714464009756 EUDAMED05714464038862 EUDAMED05714464010370 EUDAMED05714464038824 EUDAMED05714464009152 EUDAMED05714464010387 EUDAMED05714464031061 EUDAMED05714464010363 EUDAMED05714464031559 EUDAMED05714464032099 EUDAMED05714464047376 EUDAMED05714464032051 EUDAMED05714464047345 EUDAMED05714464010394 EUDAMED05714464038749 EUDAMED05714464047284 EUDAMED05714464038725 EUDAMED05714464047420 EUDAMED05714464038688 EUDAMED05714464038855 EUDAMED05714464038848 EUDAMED05714464010400 EUDAMED05714464047406 EUDAMED05714464031047 EUDAMED
- Basic UDI-DI
- 57144640-HI-00053-RB EUDAMED
- EMDN Code
- Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) EUDAMEDY2145060101 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE) EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Denmark EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Category: Air-conduction hearing aid, receiver-in-canal
Audilab by Sbo Hearing A/S — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, receiver-in-canal.
- SET CROS PURE CHARGE&GO PRL — Signia GmbH · Class IIa
- HA EVK E-FS-T USA 440 SLVGR — Widex A/S · Class IIa
- SoniTon UP6 312 trial — Sonova AG · Class IIa
- HA VIO E156 T BC LI GPH — WSAUD A/S · Class IIa
- HANSATON — Hansaton Akustik GmbH · Class II
- PHONAK — Sonova AG · Class II
- AMPLIFON — Starkey Laboratories Inc. · Class II
- NUEAR — Starkey Laboratories Inc. · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 57144640-HI-00053-RB | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SBO Hearing A/S
- EUDAMED SRN
- DK-MF-000001270
Sources (47)
- EUDAMED 030655cf-7d22-434f-9a39-a7d3fc261b43 61 fields · synced Sep 17, 2026
- EUDAMED 17d1ad61-19f0-4242-81ab-93aae78b583b 61 fields · synced May 11, 2026
- EUDAMED a90e8ddb-3822-49df-899d-4de3c1ceca8c 61 fields · synced May 16, 2026
- EUDAMED 4764d554-8aa5-4a7f-ad9e-f4fe30f86882 61 fields · synced May 16, 2026
- EUDAMED 4d8cab42-1b0d-4344-aadb-2c437c15b0e0 61 fields · synced May 16, 2026
- EUDAMED f09a8f3b-6e8e-4a6d-b8b6-bf6fdc46c552 61 fields · synced May 16, 2026
- EUDAMED a6980452-58ed-401a-b1cb-d4e4df13658e 61 fields · synced May 16, 2026
- EUDAMED 78985de4-01e4-448c-9cb9-9df76358a741 61 fields · synced May 16, 2026
- EUDAMED a225dc4f-b44f-4021-8330-0d0a5c3a8839 61 fields · synced May 16, 2026
- EUDAMED db65ccb5-e8e8-4cef-8eeb-d2f6180adfde 61 fields · synced May 16, 2026
- EUDAMED 7226394c-7c40-45dd-9b2c-459cd1ae470c 61 fields · synced May 17, 2026
- EUDAMED b9c92b27-016e-4823-a2cc-7783980b9cd4 61 fields · synced May 17, 2026
- EUDAMED 82574d70-d00c-46a0-9284-deaec212d5b5 61 fields · synced May 17, 2026
- EUDAMED bf064b89-e553-4281-845e-f80c2eb46455 61 fields · synced May 17, 2026
- EUDAMED 389f42f9-facf-4700-bad5-40deccd396b2 61 fields · synced May 17, 2026
- EUDAMED 2cffd4ad-59b7-4560-a77f-14570c0d5e81 61 fields · synced May 17, 2026
- EUDAMED 3b0f7de5-436c-433b-8347-55dd13eeb7a5 61 fields · synced May 17, 2026
- EUDAMED 781d1e23-7ba4-4fbf-ab0a-5f48460f2b26 61 fields · synced May 17, 2026
- EUDAMED b9e7a62b-68a7-4414-9e82-3889cb06ba93 61 fields · synced May 17, 2026
- EUDAMED bcc624fe-f68d-49be-bc4c-de9779a7fd34 61 fields · synced May 17, 2026
- EUDAMED a99ed916-2646-4f44-a53e-607606043f7d 61 fields · synced May 17, 2026
- EUDAMED 4b15f696-4fbd-4cc9-9539-61ba684297b4 61 fields · synced May 17, 2026
- EUDAMED 52e4d470-5b25-4c45-99f6-8aa8b8021929 61 fields · synced May 17, 2026
- EUDAMED bc10de2b-214b-47ee-bc63-fd38c857b6a3 61 fields · synced May 17, 2026
- EUDAMED c202cfa8-8814-4cbb-a07d-b33bffbadc8d 61 fields · synced May 18, 2026
- EUDAMED d436edf2-fd14-4029-9833-026f75af6d99 61 fields · synced May 18, 2026
- EUDAMED fa575a75-5ecc-46df-a491-4ee01ffcb2d3 61 fields · synced May 18, 2026
- EUDAMED 60f06af2-57ca-42d5-989f-00931a2fb502 61 fields · synced May 18, 2026
- EUDAMED c1ea1e5c-5ea8-4b14-9753-d6024009d985 61 fields · synced May 18, 2026
- EUDAMED a32f0f5e-4d92-4b97-a8da-39188cb3992e 61 fields · synced May 18, 2026
- EUDAMED f29a41c7-137d-4d1a-ad85-6c493db4fa0c 61 fields · synced May 18, 2026
- EUDAMED dbd98c0b-d91e-4c0b-a00e-3dbb7c253c8a 61 fields · synced May 18, 2026
- EUDAMED 7e314a0a-cf60-49bd-865e-5132fbb785a2 61 fields · synced May 18, 2026
- EUDAMED e34524d2-65c6-4d28-9999-30d8fad57055 61 fields · synced May 18, 2026
- EUDAMED a9fb48f8-95dc-4ba0-9cab-20ca7cf06ce3 61 fields · synced May 18, 2026
- EUDAMED 94171f19-b430-42e4-9c87-3f66316f20b3 61 fields · synced May 18, 2026
- EUDAMED fe5b672c-0250-4169-a144-e93f581ce1a4 61 fields · synced May 18, 2026
- EUDAMED 4b06eee2-49d3-4282-8c53-10289c123394 61 fields · synced May 18, 2026
- EUDAMED e89d49c1-71ce-4783-a1a3-fbe44c8d64fd 61 fields · synced May 18, 2026
- EUDAMED 3395cbbc-54c4-4591-9e2a-b2bd0a079360 61 fields · synced May 18, 2026
- EUDAMED 74c54590-03d0-4fff-8406-a6dcddfdc33c 61 fields · synced May 18, 2026
- EUDAMED ebe17e95-4a95-451f-bead-37e2a4baebd0 61 fields · synced May 19, 2026
- EUDAMED 6582632d-8296-4dc2-a6b6-c9dd8c1a7411 61 fields · synced May 19, 2026
- EUDAMED 02769187-1049-4996-8a2e-fa640e8acf35 61 fields · synced May 19, 2026
- EUDAMED 0671f236-d3bb-46d2-9c6b-94152925077a 61 fields · synced May 19, 2026
- EUDAMED a4b482cf-5ade-4baf-961a-57e07891a1ad 61 fields · synced May 19, 2026
- EUDAMED 623540d1-40a8-4aaa-9a07-bd285951d625 61 fields · synced May 19, 2026