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Pro Akustik
EUDAMEDClass IIa (EU MDR)
Ref 222213Model HI (BTE)Ref 230578Ref 240680Ref 230569Ref 222201Ref 240401Ref 230583Ref 240396Ref 222192Ref 230576Ref 240410Ref 222202Ref 222209Ref 240676Ref 240409Ref 240671Ref 240406Ref 222203Ref 222212Ref 222208Ref 240686Ref 222204Ref 240400Ref 240674Ref 222200Ref 230589Ref 222190Ref 222207Ref 240411Ref 222187Ref 222211Ref 222198Ref 240405Ref 240399Ref 240670Ref 230565Ref 222199Ref 222193Ref 230567Ref 240684Ref 240685
Identity
- Trade Name
- Pro Akustik EUDAMED
- Model / Reference
- HI (BTE) EUDAMED222213 EUDAMED230578 EUDAMED240680 EUDAMED230569 EUDAMED222201 EUDAMED240401 EUDAMED230583 EUDAMED240396 EUDAMED222192 EUDAMED230576 EUDAMED240410 EUDAMED222202 EUDAMED222209 EUDAMED240676 EUDAMED240409 EUDAMED240671 EUDAMED240406 EUDAMED222203 EUDAMED222212 EUDAMED222208 EUDAMED240686 EUDAMED222204 EUDAMED240400 EUDAMED240674 EUDAMED222200 EUDAMED230589 EUDAMED222190 EUDAMED222207 EUDAMED240411 EUDAMED222187 EUDAMED222211 EUDAMED222198 EUDAMED240405 EUDAMED240399 EUDAMED240670 EUDAMED230565 EUDAMED222199 EUDAMED222193 EUDAMED230567 EUDAMED240684 EUDAMED240685 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05714464010493 EUDAMED05714464031658 EUDAMED05714464057115 EUDAMED05714464031146 EUDAMED05714464009879 EUDAMED05714464054534 EUDAMED05714464032129 EUDAMED05714464054503 EUDAMED05714464009268 EUDAMED05714464031634 EUDAMED05714464054589 EUDAMED05714464009886 EUDAMED05714464010455 EUDAMED05714464057092 EUDAMED05714464054572 EUDAMED05714464057061 EUDAMED05714464054565 EUDAMED05714464009893 EUDAMED05714464010486 EUDAMED05714464010448 EUDAMED05714464057153 EUDAMED05714464009909 EUDAMED05714464054527 EUDAMED05714464057078 EUDAMED05714464009862 EUDAMED05714464032181 EUDAMED05714464009244 EUDAMED05714464010431 EUDAMED05714464054596 EUDAMED05714464009213 EUDAMED05714464010479 EUDAMED05714464009848 EUDAMED05714464054558 EUDAMED05714464054510 EUDAMED05714464057054 EUDAMED05714464031108 EUDAMED05714464009855 EUDAMED05714464009275 EUDAMED05714464031122 EUDAMED05714464057139 EUDAMED05714464057146 EUDAMED
- Basic UDI-DI
- 57144640-HI-00053-RB EUDAMED
- EMDN Code
- Y2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) 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
Pro Akustik by Sbo Hearing A/S — Class IIa — MDR — listed in EUDAMED — regulatory data on deviCERTS
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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 (41)
- EUDAMED 01b76d6e-ec63-416b-a5e2-348e452d2e2e 61 fields · synced Aug 4, 2026
- EUDAMED 042f6d58-6e7c-40f7-9848-3226dadb7f13 61 fields · synced May 16, 2026
- EUDAMED 35504676-d454-40cf-b86e-50e13adba3ac 61 fields · synced May 16, 2026
- EUDAMED fd8e5746-0e41-4d05-b2b4-3185eedcd746 61 fields · synced May 16, 2026
- EUDAMED d8111bec-6b69-4151-a6ac-64179fda7a02 61 fields · synced May 16, 2026
- EUDAMED c5dac457-8ed4-4d40-836c-5670fb58e6ae 61 fields · synced May 16, 2026
- EUDAMED 636f5dec-6bf4-4ecb-91f2-0b22e54da1a3 61 fields · synced May 16, 2026
- EUDAMED ae286ef3-b12f-41ab-99dc-b34c52ac2faf 61 fields · synced May 16, 2026
- EUDAMED d93ecfb2-697c-4cc4-b053-a8d0cccbae4a 61 fields · synced May 16, 2026
- EUDAMED 72f91c72-7a2d-4171-8180-9b45526be6cd 61 fields · synced May 17, 2026
- EUDAMED c5c4e0fc-aee5-4bc0-a1f6-a22bc9b7b7a0 61 fields · synced May 17, 2026
- EUDAMED 6c877439-791f-48ef-aa27-0f5f6c08b19a 61 fields · synced May 17, 2026
- EUDAMED e05372c8-6a58-4653-b639-04fcdc7dc6e9 61 fields · synced May 17, 2026
- EUDAMED 57df0787-d6cb-4e7a-a755-b15589347277 61 fields · synced May 17, 2026
- EUDAMED 1a9bf233-fdc0-47e4-a8d9-2b26dc8a25ab 61 fields · synced May 17, 2026
- EUDAMED 7e79ba14-17c6-4684-884e-9f7815becbd4 61 fields · synced May 17, 2026
- EUDAMED d099d2fa-55d4-4599-b76b-d1d4f5758fb8 61 fields · synced May 17, 2026
- EUDAMED c4edc9cf-36ea-4f99-a880-461e7fb6ad07 61 fields · synced May 17, 2026
- EUDAMED ee9478b0-ee1e-4871-9975-14520916eec1 61 fields · synced May 17, 2026
- EUDAMED 8f233d34-184e-467d-826b-a46cdd4b1a32 61 fields · synced May 17, 2026
- EUDAMED 20ccde4b-e622-437e-8649-d83331388ec2 61 fields · synced May 17, 2026
- EUDAMED 5102a8aa-243f-4257-8493-744c4be6e818 61 fields · synced May 17, 2026
- EUDAMED ad9abc4a-d32a-4351-8685-fa46c4a01629 61 fields · synced May 17, 2026
- EUDAMED 82d9a557-0134-42f5-bc20-0be50faf5730 61 fields · synced May 17, 2026
- EUDAMED 975106f1-24ae-4490-ba3b-4579c0374d25 61 fields · synced May 17, 2026
- EUDAMED 2f478d4f-bc7b-4d0f-bb79-b38f346dcd66 61 fields · synced May 18, 2026
- EUDAMED 64f35395-82ae-4a8b-95d1-46c1c883740e 61 fields · synced May 18, 2026
- EUDAMED 433971a6-9cbc-4404-b225-d08faab90391 61 fields · synced May 18, 2026
- EUDAMED e1049945-6746-4be7-929c-43f0864581f3 61 fields · synced May 18, 2026
- EUDAMED 7f435d14-c5e7-420b-9286-faa8cfed951c 61 fields · synced May 18, 2026
- EUDAMED 6ee4ca68-12d2-4445-9888-ac87c10ec62f 61 fields · synced May 18, 2026
- EUDAMED 097b0c6a-220b-41a9-9c14-dff554b4867a 61 fields · synced May 18, 2026
- EUDAMED 89788792-ba31-417c-bdbd-ae90fcb0146c 61 fields · synced May 18, 2026
- EUDAMED 5600f888-31a7-470c-9d90-1610d56e8248 61 fields · synced May 18, 2026
- EUDAMED 307d6935-6c5c-4148-a96d-7ba6bf7feead 61 fields · synced May 18, 2026
- EUDAMED 12fd62f3-0f3b-4aa9-81ce-ff6a6cf09a80 61 fields · synced May 18, 2026
- EUDAMED c023e04e-b650-41c7-bdd1-d7898774e3b4 61 fields · synced May 18, 2026
- EUDAMED 0bff1529-91fc-4431-88ca-e2047c1a1c8b 61 fields · synced May 18, 2026
- EUDAMED b8059eb8-8c8a-421d-827c-30114f0ad1d2 61 fields · synced May 19, 2026
- EUDAMED 3a5ddf0f-c215-4981-bbac-6e16b2d8b35b 61 fields · synced May 19, 2026
- EUDAMED 95d4e6f4-343d-4b0a-bbdb-b49d8d75b8ec 61 fields · synced May 19, 2026