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Hörex
EUDAMEDClass IIa (EU MDR)
Ref 222134Model HI (BTE)Ref 230513Ref 222112Ref 230526Ref 240640Ref 240350Ref 222113Ref 222123Ref 222115Ref 240343Ref 240339Ref 230514Ref 240345Ref 222121Ref 240647Ref 230515Ref 222116Ref 222120Ref 222127Ref 230529Ref 230525Ref 222126Ref 230532Ref 230521Ref 230517Ref 230537Ref 240646Ref 222137Ref 222117Ref 222133Ref 230518Ref 230535Ref 230516Ref 222130Ref 230524Ref 222109Ref 230538Ref 230522Ref 222114Ref 222110Ref 230512Ref 240353Ref 222124Ref 240354
Identity
- Trade Name
- Hörex EUDAMED
- Model / Reference
- HI (BTE) EUDAMED222134 EUDAMED230513 EUDAMED222112 EUDAMED230526 EUDAMED240640 EUDAMED240350 EUDAMED222113 EUDAMED222123 EUDAMED222115 EUDAMED240343 EUDAMED240339 EUDAMED230514 EUDAMED240345 EUDAMED222121 EUDAMED240647 EUDAMED230515 EUDAMED222116 EUDAMED222120 EUDAMED222127 EUDAMED230529 EUDAMED230525 EUDAMED222126 EUDAMED230532 EUDAMED230521 EUDAMED230517 EUDAMED230537 EUDAMED240646 EUDAMED222137 EUDAMED222117 EUDAMED222133 EUDAMED230518 EUDAMED230535 EUDAMED230516 EUDAMED222130 EUDAMED230524 EUDAMED222109 EUDAMED230538 EUDAMED230522 EUDAMED222114 EUDAMED222110 EUDAMED230512 EUDAMED240353 EUDAMED222124 EUDAMED240354 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05714464010318 EUDAMED05714464030941 EUDAMED05714464009091 EUDAMED05714464031498 EUDAMED05714464056835 EUDAMED05714464054183 EUDAMED05714464009107 EUDAMED05714464009701 EUDAMED05714464009121 EUDAMED05714464054138 EUDAMED05714464054114 EUDAMED05714464030958 EUDAMED05714464054152 EUDAMED05714464009688 EUDAMED05714464056880 EUDAMED05714464030965 EUDAMED05714464009138 EUDAMED05714464009671 EUDAMED05714464009749 EUDAMED05714464031528 EUDAMED05714464031481 EUDAMED05714464009732 EUDAMED05714464031979 EUDAMED05714464031443 EUDAMED05714464030989 EUDAMED05714464032020 EUDAMED05714464056873 EUDAMED05714464010349 EUDAMED05714464009145 EUDAMED05714464010301 EUDAMED05714464030996 EUDAMED05714464032006 EUDAMED05714464030972 EUDAMED05714464010271 EUDAMED05714464031474 EUDAMED05714464009060 EUDAMED05714464032037 EUDAMED05714464031450 EUDAMED05714464009114 EUDAMED05714464009077 EUDAMED05714464030934 EUDAMED05714464054190 EUDAMED05714464009718 EUDAMED05714464054206 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
Hörex 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 (44)
- EUDAMED 83629b1e-5eef-498c-97c7-a3440d112497 61 fields · synced Sep 17, 2026
- EUDAMED bdb75766-16df-4b8c-a6b7-c9632b4b3fe7 61 fields · synced May 11, 2026
- EUDAMED 9d156905-af7b-4496-bce5-240bda8259db 61 fields · synced May 16, 2026
- EUDAMED e51cf966-b49f-43f9-a467-36684f396cfc 61 fields · synced May 16, 2026
- EUDAMED b6373519-2f45-405c-b619-348b7e66ebbb 61 fields · synced May 16, 2026
- EUDAMED 45094760-4dee-4f9c-bcda-aae0167bcb13 61 fields · synced May 16, 2026
- EUDAMED df9f33a7-699c-4472-9cf0-9f5bb82c4b54 61 fields · synced May 16, 2026
- EUDAMED 6a90b8f8-f836-4fc8-b191-136c2c91b75e 61 fields · synced May 17, 2026
- EUDAMED d8c564b8-6a71-4953-9f93-aa60fdb0d24d 61 fields · synced May 17, 2026
- EUDAMED 58cc7775-d076-46d3-9aff-3b5063e98014 61 fields · synced May 17, 2026
- EUDAMED e0e77636-a82c-4ccf-bded-7a56b26c0136 61 fields · synced May 17, 2026
- EUDAMED ca671938-31f1-4eb3-a650-025cef2c6122 61 fields · synced May 17, 2026
- EUDAMED 64571c24-d10c-469c-991a-cb8960a98a25 61 fields · synced May 17, 2026
- EUDAMED 9986df39-1446-473c-b1a6-f8a59657ad2f 61 fields · synced May 17, 2026
- EUDAMED 4c887262-0e11-4141-9dc2-c424c12ea698 61 fields · synced May 17, 2026
- EUDAMED daa32f2f-90f8-4a06-af1b-27abee166ca5 61 fields · synced May 17, 2026
- EUDAMED 519d7bb3-3242-4819-a6da-1cb340ea3284 61 fields · synced May 17, 2026
- EUDAMED c1bfa877-a000-43d1-9f64-7227612b4419 61 fields · synced May 17, 2026
- EUDAMED 5c685e25-3196-47bf-8506-c7a35a44b704 61 fields · synced May 17, 2026
- EUDAMED 2fe23768-8e84-4a7a-b33b-8a441381facc 61 fields · synced May 17, 2026
- EUDAMED c5f704b2-900a-4db4-8a94-7b8197d02486 61 fields · synced May 17, 2026
- EUDAMED 8731e1a5-4c46-433a-bc7c-8ca3f2daada3 61 fields · synced May 17, 2026
- EUDAMED 4b62cfc6-37c1-4b20-ad0f-925375722752 61 fields · synced May 17, 2026
- EUDAMED 49f328c2-e5b8-461e-834b-853c8d1cbdda 61 fields · synced May 17, 2026
- EUDAMED 19b49470-93ba-4d5a-be80-a697d9addac0 61 fields · synced May 17, 2026
- EUDAMED 4e67944e-579d-4d81-b837-8445529328af 61 fields · synced May 17, 2026
- EUDAMED 38b5f4aa-6427-4270-aea6-1bb5d29da090 61 fields · synced May 18, 2026
- EUDAMED 8420502e-fbe2-4f37-a6f6-400b7d63dded 61 fields · synced May 18, 2026
- EUDAMED 75732e9c-9743-481b-a22c-0cca4ed4e94e 61 fields · synced May 18, 2026
- EUDAMED 5fcc42ad-a727-4fcd-8c36-9d4d7cf750c8 61 fields · synced May 18, 2026
- EUDAMED bc02e0fb-3946-43f6-8eba-0a65e286ab14 61 fields · synced May 18, 2026
- EUDAMED b8dcca4d-24b2-428c-a59d-4ecf9d892d33 61 fields · synced May 18, 2026
- EUDAMED 69302c9c-1c94-4ca4-aab5-c4ce414810f2 61 fields · synced May 18, 2026
- EUDAMED 56ea1196-0bc2-466a-b5d7-b78d24737a5c 61 fields · synced May 18, 2026
- EUDAMED 65c11654-c9d9-4f5a-87d7-6467548a083a 61 fields · synced May 18, 2026
- EUDAMED 2ea8b83d-11c1-45e8-8e29-3d163146ff3b 61 fields · synced May 18, 2026
- EUDAMED 34d0753d-3311-4e72-bcd7-0db02bbc4a46 61 fields · synced May 18, 2026
- EUDAMED 9f21b8d2-50fe-4847-aa72-c1594f440339 61 fields · synced May 18, 2026
- EUDAMED 96838467-b287-4d2f-bd68-ed3a38e83fb6 61 fields · synced May 19, 2026
- EUDAMED ccb2db79-2db1-430b-ae3d-343aea44e157 61 fields · synced May 19, 2026
- EUDAMED bdf274ac-6d65-43be-8b60-1fb47da82c60 61 fields · synced May 19, 2026
- EUDAMED 85a0f197-23ae-40ae-a347-1e3af9a5bb96 61 fields · synced May 19, 2026
- EUDAMED 29c0d335-2b77-4507-a805-04ff4cd7b1f0 61 fields · synced May 19, 2026
- EUDAMED 1d9dab71-89a1-4157-8466-fb394361850d 61 fields · synced May 19, 2026