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Philips
EUDAMEDFDA UDIClass IIa (EU MDR)
Ref 289736Model HI (BTE)Ref 289725Ref 279765Ref 289553Ref 279778Ref 285021Model OneAppRef 268272Model Hearing instrument chargerRef 279775Ref 289577Ref 279746Ref 232127Model CROS/BI-CROS transmitterRef 279756Ref 289571Ref 279757Ref 279743Ref 279766Ref 289721Ref 279742Ref 289714Ref 289569Ref 279744Ref 269544Ref 285033Model Fitting softwareRef 289579Ref 289733Ref 289567Ref 279772Ref 269543Ref 279755Ref 289561Ref 279777Ref 289709Ref 289710Ref 289582Ref 289576Ref 289715Ref 292094Model HI (ITE)Ref 289580Ref 289565Ref 289574Ref 289717Ref 289562Ref 289724Ref 269546Ref 289572Ref 269539Ref 269542Ref 269538Ref 289722Ref 289727Ref 287670Ref 279771Ref 289568Ref 279774Ref 289564Ref 269541Ref 289570Ref 289566Ref 289730Ref 279740Ref 245436Ref 279763Ref 286085Ref 279760Ref 289555Ref 289719Ref 287671Ref 279764Ref 289716Ref 269547Ref 269537Ref 232124Ref 286084Ref 292095Ref 289735Ref 287674Ref 289734Ref 289706
Identity
- Trade Name
- Philips EUDAMEDFDA UDI
- Generic Name
- Air-conduction hearing aid, canal FDA UDI
- Device Name
- HEARLINK 3030 IIC FDA UDI
- Model / Reference
- HI (BTE) EUDAMED289736 EUDAMED289725 EUDAMED279765 EUDAMED289553 EUDAMED279778 EUDAMEDOneApp EUDAMED285021 EUDAMEDHearing instrument charger EUDAMED268272 EUDAMED279775 EUDAMED289577 EUDAMED279746 EUDAMEDCROS/BI-CROS transmitter EUDAMED232127 EUDAMED279756 EUDAMED289571 EUDAMED279757 EUDAMED279743 EUDAMED279766 EUDAMED289721 EUDAMED279742 EUDAMED289714 EUDAMED289569 EUDAMED279744 EUDAMED269544 EUDAMEDFitting software EUDAMED285033 EUDAMED289579 EUDAMED289733 EUDAMED289567 EUDAMED279772 EUDAMED269543 EUDAMED279755 EUDAMED289561 EUDAMED279777 EUDAMED289709 EUDAMED289710 EUDAMED289582 EUDAMED289576 EUDAMED289715 EUDAMEDHI (ITE) EUDAMED292094 EUDAMED289580 EUDAMED289565 EUDAMED289574 EUDAMED289717 EUDAMED289562 EUDAMED289724 EUDAMED269546 EUDAMED289572 EUDAMED269539 EUDAMED269542 EUDAMED269538 EUDAMED289722 EUDAMED289727 EUDAMED287670 EUDAMED279771 EUDAMED289568 EUDAMED279774 EUDAMED289564 EUDAMED269541 EUDAMED289570 EUDAMED289566 EUDAMED289730 EUDAMED279740 EUDAMED245436 EUDAMEDFDA UDI279763 EUDAMED286085 EUDAMED279760 EUDAMED289555 EUDAMED289719 EUDAMED287671 EUDAMED279764 EUDAMED289716 EUDAMED269547 EUDAMED269537 EUDAMED232124 EUDAMED286084 EUDAMED292095 EUDAMED289735 EUDAMED287674 EUDAMED289734 EUDAMED289706 EUDAMED
- Description
- HEARLINK 3030 IIC FDA UDI
Identifiers
- Primary DI / UDI-DI
- 05714464185795 EUDAMED05714464185689 EUDAMED05714464171170 EUDAMED05714464184019 EUDAMED05714464173327 EUDAMED05714464168040 EUDAMED05714464131747 EUDAMED05714464171279 EUDAMED05714464184255 EUDAMED05714464171361 EUDAMED05714464033560 EUDAMED05714464171934 EUDAMED05714464184194 EUDAMED05714464171941 EUDAMED05714464171330 EUDAMED05714464171187 EUDAMED05714464185641 EUDAMED05714464171323 EUDAMED05714464185573 EUDAMED05714464184170 EUDAMED05714464171347 EUDAMED05714464134182 EUDAMED05714464167715 EUDAMED05714464184279 EUDAMED05714464185764 EUDAMED05714464184156 EUDAMED05714464171248 EUDAMED05714464134175 EUDAMED05714464171927 EUDAMED05714464184095 EUDAMED05714464171293 EUDAMED05714464185528 EUDAMED05714464185535 EUDAMED05714464184309 EUDAMED05714464184248 EUDAMED05714464185580 EUDAMED05714464180325 EUDAMED05714464184286 EUDAMED05714464184132 EUDAMED05714464184224 EUDAMED05714464185603 EUDAMED05714464184101 EUDAMED05714464185672 EUDAMED05714464134144 EUDAMED05714464184200 EUDAMED05714464134090 EUDAMED05714464134168 EUDAMED05714464134083 EUDAMED05714464185658 EUDAMED05714464185702 EUDAMED05714464177271 EUDAMED05714464171231 EUDAMED05714464184163 EUDAMED05714464171262 EUDAMED05714464184125 EUDAMED05714464134151 EUDAMED05714464184187 EUDAMED05714464184149 EUDAMED05714464185733 EUDAMED05714464171309 EUDAMED05714464066339 EUDAMEDFDA UDI05714464171156 EUDAMED05714464175604 EUDAMED05714464171972 EUDAMED05714464184033 EUDAMED05714464185627 EUDAMED05714464177288 EUDAMED05714464171163 EUDAMED05714464185597 EUDAMED05714464134113 EUDAMED05714464134076 EUDAMED05714464033539 EUDAMED05714464175598 EUDAMED05714464180332 EUDAMED05714464185788 EUDAMED05714464177318 EUDAMED05714464185771 EUDAMED05714464185498 EUDAMED
- Basic UDI-DI
- 57144640-HI-00055-RH EUDAMED57144640-ONEAPP-00092-KE EUDAMED57144640-HICHAR-00096-XR EUDAMED57144640-CROS-00071-KM EUDAMED57144640-HI-000015-WT EUDAMED57144640-FSW-00002-SL EUDAMED57144640-HI-00079-S7 EUDAMED57144640-ONEAPP-00091-KB EUDAMED
- Direct Marketing DI
- 05714464185795 EUDAMED05714464173327 EUDAMED
- FDA Product Code
- OSM 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) EUDAMEDY214599 HEARING AIDS - OTHER EUDAMEDY214580 HEARING AIDS OR HEARING DEVICES - ACCESSORIES EUDAMEDY2145060203 HEARING AIDS COMPLETELY-IN-THE-CANAL (CIC) EUDAMEDY2145060204 HEARING AIDS INVISIBLE-IN-THE-CANAL (IIC) EUDAMED
- GMDN Term
- Air-conduction hearing aid, canal FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I EUDAMEDClass 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
No
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
MR Unsafe FDA UDI
Category: Air-conduction hearing aid, behind-the-ear
Philips 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-00055-RH | 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 (79)
- EUDAMED 15d59521-a415-41b4-a59d-5856de136725 61 fields · synced Aug 5, 2026
- EUDAMED 73a85c8d-b35c-4e06-8cc7-6b3b34f6ba06 61 fields · synced May 11, 2026
- EUDAMED 9332145d-8b83-4bce-8500-25525a68beb7 61 fields · synced May 11, 2026
- EUDAMED 0d5513e6-22f9-498c-886d-55be986f557d 61 fields · synced May 11, 2026
- EUDAMED dc6cea90-f0c1-4752-bfb1-5b183598a9cd 61 fields · synced May 16, 2026
- EUDAMED f454fd5f-d987-4927-a7e5-321a12881ba2 61 fields · synced May 16, 2026
- EUDAMED 3af9c531-5dc9-4051-8319-ab4bd79f4fab 61 fields · synced May 16, 2026
- EUDAMED 023b5c38-0dbf-4b07-84a1-1a5c23f8876b 61 fields · synced May 16, 2026
- EUDAMED bf7a4b82-531a-4f0a-b6cc-d22747d8dcf3 61 fields · synced May 16, 2026
- EUDAMED 5cba3ddc-a12b-4d3d-8c46-83ad1eb00345 61 fields · synced May 16, 2026
- EUDAMED ca38244f-efa2-42b5-8ec0-bab6fb5c1881 61 fields · synced May 16, 2026
- EUDAMED bd31e58f-9e57-4302-ac3b-f6c8513352ff 61 fields · synced May 16, 2026
- EUDAMED c7138fb2-d126-4ace-a312-a272e7517122 61 fields · synced May 16, 2026
- EUDAMED da4953f6-9467-4a7b-9134-10a2093d0f29 61 fields · synced May 17, 2026
- EUDAMED 102e55e8-1462-4a56-a475-763ff235ffc3 61 fields · synced May 17, 2026
- EUDAMED 8de38f6d-e690-48e4-8a8a-4485a8fb4f62 61 fields · synced May 17, 2026
- EUDAMED f6fb4bb9-2b2a-43d9-9dd4-10a829a1c475 61 fields · synced May 17, 2026
- EUDAMED 6c92e329-77f4-444f-827e-b92b8e6560c3 61 fields · synced May 17, 2026
- EUDAMED d2abd30e-b96c-4568-92e7-21c7e37ed423 61 fields · synced May 17, 2026
- EUDAMED b8698d88-846a-479c-a523-be02d2807b69 61 fields · synced May 17, 2026
- EUDAMED 619c0234-cd16-43d9-be56-542998e9132a 61 fields · synced May 17, 2026
- EUDAMED 11fba35a-7d75-465e-a312-4fe44bebbab5 61 fields · synced May 17, 2026
- EUDAMED d85580e6-7b23-4065-ac64-b4092acf8ec7 61 fields · synced May 17, 2026
- EUDAMED 1c4bc7f0-7ddc-40de-95df-05d4703b52c4 61 fields · synced May 17, 2026
- EUDAMED 270465a5-49b5-4443-8ee1-8ad2fe077bf4 61 fields · synced May 17, 2026
- EUDAMED c9102bf9-3e2b-40cf-b811-cb353b111c21 61 fields · synced May 17, 2026
- EUDAMED 8cf95886-6b3f-4123-b46c-73ff92114473 61 fields · synced May 17, 2026
- EUDAMED 6b700f09-9834-4887-8c06-b2661e92f198 61 fields · synced May 17, 2026
- EUDAMED de65c2b3-fab6-46a4-bf3e-db6794c1fe8e 61 fields · synced May 17, 2026
- EUDAMED dd11ed5d-a47e-412e-afd6-c57754664801 61 fields · synced May 17, 2026
- EUDAMED 98a52670-2889-4af6-8c68-644c83595f48 61 fields · synced May 17, 2026
- EUDAMED 7346d494-1ef4-4103-85be-44d3fa527cdb 61 fields · synced May 17, 2026
- EUDAMED 493dd842-895d-445c-8f7d-b875f1046f8d 61 fields · synced May 17, 2026
- EUDAMED 8d266fae-7fae-4ace-bdfc-ce2de6ad5a7a 61 fields · synced May 18, 2026
- EUDAMED ea84f6c5-95c4-49f8-b390-ee90f135ad57 61 fields · synced May 18, 2026
- EUDAMED 0c9d4245-dcb9-43fd-bce9-d8cd4f6aada8 61 fields · synced May 18, 2026
- EUDAMED 2e082f36-b1ac-4e34-a576-f68dc3ae3189 61 fields · synced May 18, 2026
- EUDAMED 01ca9e30-812a-4592-a6b7-7a79ad262303 61 fields · synced May 18, 2026
- EUDAMED 8243a1a1-5091-4bad-a9d9-5b7039690297 61 fields · synced May 18, 2026
- EUDAMED dc033659-7beb-461e-9940-25765b2a5ae0 61 fields · synced May 18, 2026
- EUDAMED f2c07ad4-1c09-4671-921c-fff0f19371d9 61 fields · synced May 18, 2026
- EUDAMED 374e3a9f-b7de-4f0c-a3c4-7219e1f3fdcd 61 fields · synced May 18, 2026
- EUDAMED 4b8e6e6e-da56-49c4-a96d-13d9a7e85c14 61 fields · synced May 18, 2026
- EUDAMED 165d523b-10a0-4015-a75a-aec04d798bba 61 fields · synced May 18, 2026
- EUDAMED 1f087c0c-3870-408e-9c7b-6753bc55c919 61 fields · synced May 18, 2026
- EUDAMED 84205d21-13ac-45a8-90a7-e366c4ae1354 61 fields · synced May 18, 2026
- EUDAMED b826801d-72fb-4c25-bd10-9fcfe0462701 61 fields · synced May 18, 2026
- EUDAMED a9bfff70-f1cd-4466-843b-8b51feced35e 61 fields · synced May 18, 2026
- EUDAMED a0be0aa5-f0ca-41eb-ad02-8d73f29dc0df 61 fields · synced May 18, 2026
- EUDAMED 5dc91ac2-79d7-46b5-ad7e-00edd84d781e 61 fields · synced May 18, 2026
- EUDAMED 89e98266-fb69-4f3e-969c-00b81355e2c8 61 fields · synced May 18, 2026
- EUDAMED abfe18d9-6740-4692-a788-d3727b77ada1 61 fields · synced May 18, 2026
- EUDAMED 9c505b42-692b-4824-acc0-f63f1b921848 61 fields · synced May 18, 2026
- EUDAMED d815cebc-791a-4f74-954d-c33da0060c34 61 fields · synced May 18, 2026
- EUDAMED 0fbf783a-fe77-4924-b7af-c3d70296c1c5 61 fields · synced May 18, 2026
- EUDAMED 793e1476-792f-49cb-a1cc-d08674e5eb2c 61 fields · synced May 18, 2026
- EUDAMED fcacabd1-b8d7-40cf-a57b-62f504577073 61 fields · synced May 18, 2026
- EUDAMED 883c48a4-e199-4225-afa3-161ebd682c81 61 fields · synced May 18, 2026
- EUDAMED 5bcbaf2a-47b7-410b-b6e6-541092130785 61 fields · synced May 18, 2026
- EUDAMED 09990f0b-dac0-42c7-bd02-f3909a6e69b6 61 fields · synced May 18, 2026
- EUDAMED ad70a4a4-fc5a-4e8d-8132-8f5173406700 61 fields · synced May 18, 2026
- EUDAMED b3fe1f75-8651-433e-b139-5349d0c7b3d8 61 fields · synced May 18, 2026
- EUDAMED 8e3cb224-f675-4bf1-88cd-ffd9ae06f640 61 fields · synced May 18, 2026
- EUDAMED 5971c277-2cc1-443a-a962-7a47d0e6b63c 61 fields · synced May 18, 2026
- EUDAMED 911a470c-7560-4ae9-8012-c3fa890312d0 61 fields · synced May 18, 2026
- EUDAMED 5f520fa7-58cd-4999-b3f7-a73cc2e2cc53 61 fields · synced May 18, 2026
- EUDAMED ad160447-7156-4a5c-bdf8-753bb4873404 61 fields · synced May 18, 2026
- EUDAMED 450b3b79-c170-41d1-977d-5a34f813139b 61 fields · synced May 18, 2026
- EUDAMED 6279239e-f58a-4e0d-8bb8-c92ef379c96a 61 fields · synced May 18, 2026
- EUDAMED bedea0d4-5732-4537-8d46-4825d0ff176c 61 fields · synced May 18, 2026
- EUDAMED 909b9f9d-91ad-4a89-af31-e020d530c0a5 61 fields · synced May 19, 2026
- EUDAMED d788edd7-1db3-46bc-b5b5-a5faf44236a9 61 fields · synced May 19, 2026
- EUDAMED 6cfa5359-c033-495b-83eb-963dcf53a899 61 fields · synced May 19, 2026
- EUDAMED 5b26e464-e006-4bc8-8906-dabb7a46839c 61 fields · synced May 19, 2026
- EUDAMED 2bedb82c-684b-4554-bca0-d3981271f1f1 61 fields · synced May 19, 2026
- EUDAMED 75057adc-7e80-4fc4-9267-b19ea2bff0ac 61 fields · synced May 19, 2026
- EUDAMED 85721e36-a90c-4bb0-8e77-7878237ad4a4 61 fields · synced May 19, 2026
- EUDAMED 1f98f6a2-4f4c-449a-8167-6b88f0f2e08d 61 fields · synced May 19, 2026
- FDA UDI b889b659-6621-4acc-a65a-9780b038a9bd 34 fields · synced May 30, 2026