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Agxo
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 285376Model HI (BTE)Ref 289814Ref 259551Ref 230319Ref 290126Ref 289793Ref 285378Ref 279905Ref 289800Ref 290141Ref 290890Ref 279898Ref 290124Ref 289792Ref 279911Ref 279890Ref 283369Model HI (ITE)Ref 285373Ref 285358Ref 290874Ref 290123Ref 289789Ref 230331Ref 285340Ref 279900Ref 286075Model Fitting SoftwareRef 289807Ref 289801Ref 230320Ref 290871Ref 230335Ref 230333Ref 279896Ref 279903Ref 230329Ref 230339Ref 230327Ref 283366Ref 290859Ref 283367Ref 289812Ref 290863Ref 290143Ref 290864Ref 289794Ref 279899Ref 290152Ref 285384Ref 290861Ref 283368Ref 285385Ref 290872Ref 285352Ref 290142Ref 285365Ref 283370Ref 285348Ref 290892Ref 279891Ref 279888Ref 285363Ref 279915Ref 230317Ref 279916Ref 290882Ref 279897Ref 290121Ref 285382Ref 279902Ref 290155Ref 289797Ref 285354Ref 285364Ref 279886Ref 290132Ref 289780Ref 290122Ref 290139Ref 230330Ref 230318Ref 285371Ref 279917Ref 289813Ref 290138Ref 285379Ref 290889Ref 285353Ref 279909Ref 290150Ref 285359Ref 290136Ref 290875Ref 279885Ref 230322Ref 285341Ref 285381Ref 285369Ref 290154Ref 285349Ref 289782Ref 285370Ref 290119Ref 285343Ref 290135
Identity
- Trade Name
- AGXO EUDAMEDFDA UDI
- Generic Name
- Air-conduction hearing aid, behind-the-ear FDA UDI
- Device Name
- AGXO E500 MINIBTE R C090 FDA UDI
- Model / Reference
- HI (BTE) EUDAMED285376 EUDAMED289814 EUDAMED259551 EUDAMEDFDA UDI230319 EUDAMED290126 EUDAMED289793 EUDAMED285378 EUDAMED279905 EUDAMED289800 EUDAMED290141 EUDAMED290890 EUDAMED279898 EUDAMED290124 EUDAMED289792 EUDAMED279911 EUDAMED279890 EUDAMEDHI (ITE) EUDAMED283369 EUDAMED285373 EUDAMED285358 EUDAMED290874 EUDAMED290123 EUDAMED289789 EUDAMED230331 EUDAMED285340 EUDAMED279900 EUDAMEDFitting Software EUDAMED286075 EUDAMED289807 EUDAMED289801 EUDAMED230320 EUDAMED290871 EUDAMED230335 EUDAMED230333 EUDAMED279896 EUDAMED279903 EUDAMED230329 EUDAMED230339 EUDAMED230327 EUDAMED283366 EUDAMED290859 EUDAMED283367 EUDAMED289812 EUDAMED290863 EUDAMED290143 EUDAMED290864 EUDAMED289794 EUDAMED279899 EUDAMED290152 EUDAMED285384 EUDAMED290861 EUDAMED283368 EUDAMED285385 EUDAMED290872 EUDAMED285352 EUDAMED290142 EUDAMED285365 EUDAMED283370 EUDAMED285348 EUDAMED290892 EUDAMED279891 EUDAMED279888 EUDAMED285363 EUDAMED279915 EUDAMED230317 EUDAMED279916 EUDAMED290882 EUDAMED279897 EUDAMED290121 EUDAMED285382 EUDAMED279902 EUDAMED290155 EUDAMED289797 EUDAMED285354 EUDAMED285364 EUDAMED279886 EUDAMED290132 EUDAMED289780 EUDAMED290122 EUDAMED290139 EUDAMED230330 EUDAMED230318 EUDAMED285371 EUDAMED279917 EUDAMED289813 EUDAMED290138 EUDAMED285379 EUDAMED290889 EUDAMED285353 EUDAMED279909 EUDAMED290150 EUDAMED285359 EUDAMED290136 EUDAMED290875 EUDAMED279885 EUDAMED230322 EUDAMED285341 EUDAMED285381 EUDAMED285369 EUDAMED290154 EUDAMED285349 EUDAMED289782 EUDAMED285370 EUDAMED290119 EUDAMED285343 EUDAMED290135 EUDAMED
- Description
- AGXO E500 MINIBTE R C090 FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05714464169078 EUDAMED05714464186549 EUDAMED05714464101757 EUDAMEDFDA UDI05714464029280 EUDAMED05714464188727 EUDAMED05714464186334 EUDAMED05714464169092 EUDAMED05714464171668 EUDAMED05714464186402 EUDAMED05714464188871 EUDAMED05714464199419 EUDAMED05714464171590 EUDAMED05714464188703 EUDAMED05714464186327 EUDAMED05714464171729 EUDAMED05714464171514 EUDAMED05714464169436 EUDAMED05714464169047 EUDAMED05714464168897 EUDAMED05714464199259 EUDAMED05714464188697 EUDAMED05714464186297 EUDAMED05714464029884 EUDAMED05714464168712 EUDAMED05714464171613 EUDAMED05714464175505 EUDAMED05714464186471 EUDAMED05714464186419 EUDAMED05714464029297 EUDAMED05714464199228 EUDAMED05714464030408 EUDAMED05714464030385 EUDAMED05714464171576 EUDAMED05714464171644 EUDAMED05714464029860 EUDAMED05714464030446 EUDAMED05714464029846 EUDAMED05714464169405 EUDAMED05714464199105 EUDAMED05714464169412 EUDAMED05714464186525 EUDAMED05714464199143 EUDAMED05714464188895 EUDAMED05714464199150 EUDAMED05714464186341 EUDAMED05714464171606 EUDAMED05714464188987 EUDAMED05714464169153 EUDAMED05714464199129 EUDAMED05714464169429 EUDAMED05714464169160 EUDAMED05714464199235 EUDAMED05714464168835 EUDAMED05714464188888 EUDAMED05714464168965 EUDAMED05714464169443 EUDAMED05714464168798 EUDAMED05714464199433 EUDAMED05714464171521 EUDAMED05714464171491 EUDAMED05714464168941 EUDAMED05714464171767 EUDAMED05714464029266 EUDAMED05714464171774 EUDAMED05714464199334 EUDAMED05714464171583 EUDAMED05714464188673 EUDAMED05714464169139 EUDAMED05714464171637 EUDAMED05714464189014 EUDAMED05714464186372 EUDAMED05714464168859 EUDAMED05714464168958 EUDAMED05714464171477 EUDAMED05714464188789 EUDAMED05714464186204 EUDAMED05714464188680 EUDAMED05714464188857 EUDAMED05714464029877 EUDAMED05714464029273 EUDAMED05714464169023 EUDAMED05714464171781 EUDAMED05714464186532 EUDAMED05714464188840 EUDAMED05714464169108 EUDAMED05714464199402 EUDAMED05714464168842 EUDAMED05714464171705 EUDAMED05714464188963 EUDAMED05714464168903 EUDAMED05714464188826 EUDAMED05714464199266 EUDAMED05714464171460 EUDAMED05714464029310 EUDAMED05714464168729 EUDAMED05714464169122 EUDAMED05714464169009 EUDAMED05714464189007 EUDAMED05714464168804 EUDAMED05714464186228 EUDAMED05714464169016 EUDAMED05714464188659 EUDAMED05714464168743 EUDAMED05714464188819 EUDAMED
- Basic UDI-DI
- 57144640-HI-00052-R8 EUDAMED57144640-HI-00076-RW EUDAMED57144640-fSW-000011-25 EUDAMED
- FDA Product Code
- KLW FDA UDIOSM FDA UDI
- EMDN Code
- Y2145060101 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE DEVICE (BTE) EUDAMEDY2145060102 BEHIND-THE-EAR HEARING AIDS WITH RECEIVER IN THE CANAL (RIC, RITE) EUDAMEDY2145060203 HEARING AIDS COMPLETELY-IN-THE-CANAL (CIC) EUDAMEDY214599 HEARING AIDS - OTHER EUDAMED
- GMDN Term
- Air-conduction hearing aid, behind-the-ear FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 874.3400 FDA UDI874.3305 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
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
MR Unsafe FDA UDI
Category: Air-conduction hearing aid, behind-the-ear
Agxo by Sbo Hearing A/S — Class IIa — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Air-conduction hearing aid, behind-the-ear.
- Oticon — Oticon A/S · Class II
- Amplifon — Sonova AG · Class II
- Phonak Naída L30-SP — Sonova AG · Class II
- Phonak — Phonak, Inc. · Class II
- GN ReSound — Gn Hearing A/S · Class II
- Miracle-Ear — WS Audiology USA, Inc. · Class II
- NUEAR — Starkey Laboratories Inc. · Class II
- HHM — Oticon A/S · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 57144640-HI-00052-R8 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- SBO Hearing A/S
- EUDAMED SRN
- DK-MF-000001270
Sources (105)
- EUDAMED 259d8749-554e-4069-b723-1f1b9be91e79 61 fields · synced Sep 18, 2026
- EUDAMED 9d1899eb-4c1f-4eeb-892b-fe1999225179 61 fields · synced May 16, 2026
- EUDAMED 8ca7947e-74f6-4d6d-9023-3c34395dece3 61 fields · synced May 16, 2026
- EUDAMED a140f073-e81a-4848-afd8-13dae978cafe 61 fields · synced May 16, 2026
- EUDAMED e776557d-9bb2-4c4a-8be9-458f02a4d29d 61 fields · synced May 16, 2026
- EUDAMED a3ce8b2b-752a-4b8c-8a24-d3f0daf0b4c7 61 fields · synced May 16, 2026
- EUDAMED 660a1b9a-2bfa-480f-b69a-ec6baa77987a 61 fields · synced May 16, 2026
- EUDAMED 7fce9f41-2380-45f8-a2f6-4739ec3d3455 61 fields · synced May 16, 2026
- EUDAMED 37ad2803-aa75-431d-b193-f899fa7064f2 61 fields · synced May 16, 2026
- EUDAMED 4eb4bece-e8cd-4783-bc53-f762b6aad825 61 fields · synced May 16, 2026
- EUDAMED 46f66f6f-f6f1-4f7e-9ccf-427ebd6736cf 61 fields · synced May 16, 2026
- EUDAMED cf00fdb4-461e-4555-8da4-0a55e94ab3f5 61 fields · synced May 16, 2026
- EUDAMED c4283ac2-84e5-400d-be51-5647cabbba37 61 fields · synced May 16, 2026
- EUDAMED 9e1659be-f734-4011-b319-fd8374d372b8 61 fields · synced May 16, 2026
- EUDAMED 9bdb3db4-7841-437c-acf7-07cd1ed307d2 61 fields · synced May 16, 2026
- EUDAMED 63adabca-b045-4238-ae8e-6339b66c322d 61 fields · synced May 16, 2026
- EUDAMED f9976467-87b3-45b2-942d-be3cb27553fe 61 fields · synced May 16, 2026
- EUDAMED a9c0da6d-da6f-4efb-8db7-1c8a83dfa94d 61 fields · synced May 16, 2026
- EUDAMED 3341966e-1453-408b-be01-b778734ab6e3 61 fields · synced May 16, 2026
- EUDAMED 55c3bd0c-a5d7-4b86-bfe9-c5a8bacc7386 61 fields · synced May 16, 2026
- EUDAMED b1eee5df-2a66-457e-8fab-21680865b365 61 fields · synced May 17, 2026
- EUDAMED 31881d4f-9f7d-44ed-9d64-b4375f12b9de 61 fields · synced May 17, 2026
- EUDAMED 3972f732-fdb6-4b04-b33b-44c179fa9787 61 fields · synced May 17, 2026
- EUDAMED f09be29a-9be4-4dbf-9ed2-679271972142 61 fields · synced May 17, 2026
- EUDAMED 171c5dcd-9561-423b-a277-a23fa7aeb469 61 fields · synced May 17, 2026
- EUDAMED 0a307a7f-0b3e-440e-b2ef-f3ba87e62e21 61 fields · synced May 17, 2026
- EUDAMED fa47a579-a04a-461c-a3b0-309aa7f813c3 61 fields · synced May 17, 2026
- EUDAMED 456655b8-b183-4f13-a33d-2f3faded7f95 61 fields · synced May 17, 2026
- EUDAMED e44e889e-026e-4305-969a-7c6307ee69a4 61 fields · synced May 17, 2026
- EUDAMED af8156d6-fcc4-4999-97e6-50aa6132a372 61 fields · synced May 17, 2026
- EUDAMED 8063af9d-a9d2-4549-9305-35bd7f54a82e 61 fields · synced May 17, 2026
- EUDAMED b44fe8b6-98e7-4cbe-a5b0-c07bf843dd21 61 fields · synced May 17, 2026
- EUDAMED 2d9d90fd-44ab-4bde-8a89-e5a0b40daaa1 61 fields · synced May 17, 2026
- EUDAMED d0e8c5d0-a5dd-456b-8a20-ef866523347a 61 fields · synced May 17, 2026
- EUDAMED 2897a0f6-2d43-40ac-a785-4d9f4840a443 61 fields · synced May 17, 2026
- EUDAMED 84c77b2a-39f7-4ae0-b755-a9afa6d9903a 61 fields · synced May 17, 2026
- EUDAMED 883a7fa3-b880-4edc-86b9-3e4b24490048 61 fields · synced May 17, 2026
- EUDAMED 4b2ade89-5c4d-4364-802b-a8f5c7b20af3 61 fields · synced May 17, 2026
- EUDAMED 50e24626-142b-49db-a4b8-3bc5c18026e7 61 fields · synced May 17, 2026
- EUDAMED 0683fa24-0e64-4219-a6c5-186db0d6f13a 61 fields · synced May 17, 2026
- EUDAMED a9216e83-4a16-4dfd-b916-c6c321ccd570 61 fields · synced May 17, 2026
- EUDAMED da342b27-a1d5-4f14-b921-cbec1485d823 61 fields · synced May 17, 2026
- EUDAMED ab2fd412-d6eb-4385-96ae-cc02e1cee3d4 61 fields · synced May 17, 2026
- EUDAMED 3e14883c-6633-457b-a436-01891bac2e3b 61 fields · synced May 17, 2026
- EUDAMED 50747b37-b85c-4a1e-9432-5fc5f77501c5 61 fields · synced May 17, 2026
- EUDAMED 788d7d76-3807-4031-a163-d7bf3ccb8020 61 fields · synced May 17, 2026
- EUDAMED 400b3c20-b3cc-4006-9051-9ab5b40da3f4 61 fields · synced May 17, 2026
- EUDAMED b845b226-fccc-4b07-8ae5-f39b459c9eaf 61 fields · synced May 17, 2026
- EUDAMED e6189fc4-1b57-4fb5-b080-e050f8d8e754 61 fields · synced May 17, 2026
- EUDAMED 37b898e0-b9a5-4c29-b5e3-1ea794ead4de 61 fields · synced May 17, 2026
- EUDAMED a97ada53-afcf-478f-b81f-187919371171 61 fields · synced May 17, 2026
- EUDAMED 51984d84-165d-4e22-9774-8cef95649572 61 fields · synced May 18, 2026
- EUDAMED 342e6d8e-19d7-4553-a67b-ae4e3511d329 61 fields · synced May 18, 2026
- EUDAMED 80272b31-356c-415d-b38e-dd5cc8f405ac 61 fields · synced May 18, 2026
- EUDAMED 21aa2936-a122-4e6d-b2db-c959fe560c04 61 fields · synced May 18, 2026
- EUDAMED f78e9ab8-f2d7-43df-a17c-be94cb8e40bd 61 fields · synced May 18, 2026
- EUDAMED b78097d5-d161-4e6e-8b07-278d3122fe4a 61 fields · synced May 18, 2026
- EUDAMED 85328bbe-f451-402e-938d-c2c1e4ec02a1 61 fields · synced May 18, 2026
- EUDAMED 34af0463-40e7-4ddc-8602-729abc2b29f8 61 fields · synced May 18, 2026
- EUDAMED fc6b3d85-2bc6-4eb6-b4f8-34688ac9294a 61 fields · synced May 18, 2026
- EUDAMED 07a514d8-769f-46d1-9ba1-7cd01a561234 61 fields · synced May 18, 2026
- EUDAMED 46d23382-5f78-4fec-a8d6-6be32bc1a025 61 fields · synced May 18, 2026
- EUDAMED 950d02f1-82e6-4c09-a000-f718160f9351 61 fields · synced May 18, 2026
- EUDAMED ee0056b2-d539-4041-a0cc-3f90b60e29ca 61 fields · synced May 18, 2026
- EUDAMED c716ac52-2359-4963-801a-9fdcfab94616 61 fields · synced May 18, 2026
- EUDAMED 79b97ff1-6fa5-4459-a1de-23a3a884a456 61 fields · synced May 18, 2026
- EUDAMED 722dc419-82c7-4b2a-a8a1-9259ec152be6 61 fields · synced May 18, 2026
- EUDAMED 2399a2b8-51d0-44f6-9a98-857bd3160e78 61 fields · synced May 18, 2026
- EUDAMED dd6bd9c8-39f6-4ba8-9ead-9ef14221b26c 61 fields · synced May 18, 2026
- EUDAMED ec03524f-ad6e-4029-afcb-d0c239b00246 61 fields · synced May 18, 2026
- EUDAMED ed48ea3d-5a4f-46f4-9d40-cc296d823d22 61 fields · synced May 18, 2026
- EUDAMED 3fe30f65-584f-4200-9186-ebe4c75881ae 61 fields · synced May 18, 2026
- EUDAMED 106fa0d0-a4de-4836-8f43-83f90b5a3762 61 fields · synced May 18, 2026
- EUDAMED 1f1a7656-52a2-4c54-8305-5746ea63ca70 61 fields · synced May 18, 2026
- EUDAMED 9e86a61d-aa7a-49de-ba91-70d7f41cca30 61 fields · synced May 18, 2026
- EUDAMED 9a13836e-526a-40e3-ba69-4a8d7cec8376 61 fields · synced May 18, 2026
- EUDAMED 17da4fc1-7b31-4c02-becd-ba59caf8fdc3 61 fields · synced May 18, 2026
- EUDAMED 2d2c80eb-9772-4668-bea6-94e10c87d501 61 fields · synced May 18, 2026
- EUDAMED f5bf0d7c-96f5-46d7-bc03-f55704839c7a 61 fields · synced May 18, 2026
- EUDAMED c8e0a951-0562-419a-a9e3-887b3dd9b474 61 fields · synced May 18, 2026
- EUDAMED a29fa5c2-4cfd-4a45-b08d-453b2e8024cd 61 fields · synced May 18, 2026
- EUDAMED f255b56c-df82-4de2-a648-7e40399c9f22 61 fields · synced May 18, 2026
- EUDAMED 5c5a0c37-bb2d-46d8-8031-d9c03e003748 61 fields · synced May 18, 2026
- EUDAMED 8e355967-5380-4262-bb8d-83d4302e0d35 61 fields · synced May 18, 2026
- EUDAMED 1581e17b-0ac5-436c-a13d-4978f0a1ce2a 61 fields · synced May 18, 2026
- EUDAMED fe18caa4-a80a-46ae-b1a3-99eaec6aef93 61 fields · synced May 18, 2026
- EUDAMED 849a8529-0d5c-4af1-b04f-6156d50715eb 61 fields · synced May 18, 2026
- EUDAMED c3580312-692b-4575-8211-72de703bba29 61 fields · synced May 18, 2026
- EUDAMED b5557b83-213f-47b2-bc89-e0d2af74e2ef 61 fields · synced May 18, 2026
- EUDAMED e0c37fe4-d47a-4ccf-b651-b7ea4f0e9444 61 fields · synced May 18, 2026
- EUDAMED 4b0f26ae-aeb6-49c2-8510-3be21a4a7eec 61 fields · synced May 18, 2026
- EUDAMED 5f5d9262-715d-44c1-972e-5323200adc38 61 fields · synced May 18, 2026
- EUDAMED 8cb6d046-5034-4105-944a-29fa88931f5f 61 fields · synced May 18, 2026
- EUDAMED 373e8985-aa77-47bc-af67-71c556040296 61 fields · synced May 18, 2026
- EUDAMED 4099ed31-2ef8-4080-bd06-ff5fb1087727 61 fields · synced May 19, 2026
- EUDAMED 81bab0c1-187c-47dc-80bb-9cfdf8a9c8b2 61 fields · synced May 19, 2026
- EUDAMED 2ac8e05c-ddb8-49dd-b34d-a506fb987dad 61 fields · synced May 19, 2026
- EUDAMED d7a91586-cc5c-4994-bee2-24bb32b3bddd 61 fields · synced May 19, 2026
- EUDAMED 714691ec-9682-4475-8757-4f6415e774be 61 fields · synced May 19, 2026
- EUDAMED 34d9add3-2779-4b35-ab40-08bfda00bb1e 61 fields · synced May 19, 2026
- EUDAMED 3b1dbf05-768b-49d2-9842-55e97d1b0422 61 fields · synced May 19, 2026
- EUDAMED 2349cab8-fdbe-436e-bad9-6681c0f4618a 61 fields · synced May 19, 2026
- EUDAMED a95f78cf-2836-4dce-b4c0-a0fef1b32389 61 fields · synced May 19, 2026
- EUDAMED dc5f2761-7f52-49f2-89b4-dc5e3ef6565d 61 fields · synced May 19, 2026
- FDA UDI d854d8ec-63e1-4148-aefc-d4641ebf958e 34 fields · synced May 30, 2026