Bernafon
Bernafon Entra B 20 MNR T R Sabe/Msil Demo
4manufacturers in China registered for this device type
226catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Fujian (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| GN Resound China, Ltd. | Xiamen | Fujian | Contract manufacturer | 7 |
| Sonova Hearing (Suzhou) Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 3 |
| Jiangsu Betterlife Medical Co., Ltd. | Jiangsu | Jiangsu | Manufacturer | 4 |
| Starkey (Suzhou) Hearing Technology Co., Ltd. | Guoxiang, Wuzhong District, Suzhou | Jiangsu | Manufacturer | 3 |
Record
| Listed by | Sbo Hearing A/S |
|---|---|
| FDA product code | KLW |
| Device type | Masker, Tinnitus |
| Device class | Class 2 |
| Regulation | 21 CFR 874.3400 |
| Premarket notification | Exempt |
| Record published | 2020-12-16 |
| Record revised | 2025-03-24 (version 5) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2028-10-03 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 220605 | In distribution | |
| 257384 | In distribution | |
| 290686 | In distribution | |
| 289521 | In distribution | |
| 289602 | In distribution | |
| 285055 | In distribution | |
| 262873 | In distribution | |
| 289532 | In distribution | |
| 276162 | In distribution | |
| 262913 | In distribution | |
| 289615 | In distribution | |
| 255347 | In distribution | |
| 276380 | In distribution | |
| 289503 | In distribution | |
| 290677 | In distribution | |
| 274965 | In distribution | |
| 289632 | In distribution | |
| 276386 | In distribution | |
| 279570 | In distribution | |
| 215176 | In distribution | |
| 256390 | In distribution | |
| 257721 | In distribution | |
| 287660 | In distribution | |
| 290673 | In distribution | |
| 276161 | In distribution | |
| 281605 | In distribution | |
| 228200 | In distribution | |
| 276598 | In distribution | |
| 269946 | In distribution | |
| 262872 | In distribution | |
| 279560 | In distribution | |
| 289628 | In distribution | |
| 276709 | In distribution | |
| 257370 | In distribution | |
| 256397 | In distribution | |
| 285058 | In distribution | |
| 256368 | In distribution | |
| 286066 | In distribution | |
| 279577 | In distribution | |
| 279569 | In distribution | |
| 276597 | In distribution | |
| 256374 | In distribution | |
| 234035 | In distribution | |
| 269937 | In distribution | |
| 230059 | In distribution | |
| 270487 | In distribution | |
| 279554 | In distribution | |
| 269351 | In distribution | |
| 290670 | In distribution | |
| 269948 | In distribution | |
| 285056 | In distribution | |
| 279558 | In distribution | |
| 279551 | In distribution | |
| 286143 | In distribution | |
| 276894 | In distribution | |
| 265712 | In distribution | |
| 271201 | In distribution | |
| 246122 | In distribution | |
| 234028 | In distribution | |
| 279576 | In distribution | |
| 262922 | In distribution | |
| 214982 | In distribution | |
| 289507 | In distribution | |
| 289635 | In distribution | |
| 231716 | In distribution | |
| 290669 | In distribution | |
| 229305 | In distribution | |
| 290641 | In distribution | |
| 220589 | In distribution | |
| 247382 | In distribution | |
| 273924 | In distribution | |
| 276900 | In distribution | |
| 276375 | In distribution | |
| 290691 | In distribution | |
| 246119 | In distribution | |
| 289531 | In distribution | |
| 220601 | In distribution | |
| 240610 | In distribution | |
| 289506 | In distribution | |
| 289523 | In distribution | |
| 279572 | In distribution | |
| 289609 | In distribution | |
| 246115 | In distribution | |
| 289608 | In distribution | |
| 285057 | In distribution | |
| 270502 | In distribution | |
| 276488 | In distribution | |
| 285111 | In distribution | |
| 274963 | In distribution | |
| 230057 | In distribution | |
| 276600 | In distribution | |
| 265713 | In distribution | |
| 265978 | In distribution | |
| 276715 | In distribution | |
| 276491 | In distribution | |
| 256376 | In distribution | |
| 247387 | In distribution | |
| 289517 | In distribution | |
| 228221 | In distribution | |
| 289606 | In distribution | |
| 276490 | In distribution | |
| 279573 | In distribution | |
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| 214979 | In distribution | |
| 290668 | In distribution | |
| 289502 | In distribution | |
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| 286144 | In distribution | |
| 293077 | In distribution | |
| 289607 | In distribution | |
| 220607 | In distribution | |
| 290640 | In distribution | |
| 289528 | In distribution | |
| 279564 | In distribution | |
| 279563 | In distribution | |
| 274910 | In distribution | |
| 270494 | In distribution | |
| 257380 | In distribution | |
| 246121 | In distribution | |
| 289512 | In distribution | |
| 231714 | In distribution | |
| 274911 | In distribution | |
| 269944 | In distribution | |
| 200300 | In distribution | |
| 256388 | In distribution | |
| 290674 | In distribution | |
| 276899 | In distribution | |
| 289505 | In distribution | |
| 286142 | In distribution | |
| 286077 | In distribution | |
| 257377 | In distribution | |
| 285027 | In distribution | |
| 269945 | In distribution | |
| 220599 | In distribution | |
| 279557 | In distribution | |
| 269949 | In distribution | |
| 270509 | In distribution | |
| 276601 | In distribution | |
| 269935 | In distribution | |
| 276495 | In distribution | |
| 264781 | In distribution | |
| 279575 | In distribution | |
| 276603 | In distribution | |
| 269942 | In distribution | |
| 285031 | In distribution | |
| 276376 | In distribution | |
| 279574 | In distribution | |
| 240044 | In distribution | |
| 226286 | In distribution | |
| 290639 | In distribution | |
| 246108 | In distribution | |
| 271206 | In distribution | |
| 290638 | In distribution | |
| 262914 | In distribution | |
| 269936 | In distribution | |
| 246124 | In distribution | |
| 279556 | In distribution | |
| 229304 | In distribution | |
| 290684 | In distribution | |
| 276595 | In distribution | |
| 276707 | In distribution | |
| 269940 | In distribution | |
| 289526 | In distribution | |
| 240046 | In distribution | |
| 256371 | In distribution | |
| 257367 | In distribution | |
| 226356 | In distribution | |
| 256375 | In distribution | |
| 276381 | In distribution | |
| 255346 | In distribution | |
| 289500 | In distribution | |
| 289630 | In distribution | |
| 228215 | In distribution | |
| 270488 | In distribution | |
| 257382 | In distribution | |
| 278450 | In distribution | |
| 257379 | In distribution | |
| 276384 | In distribution | |
| 257386 | In distribution | |
| 289627 | In distribution | |
| 276895 | In distribution | |
| 289622 | In distribution | |
| 231715 | In distribution | |
| 274967 | In distribution | |
| 247385 | In distribution | |
| 274908 | In distribution | |
| 289519 | In distribution | |
| 289623 | In distribution | |
| 240611 | In distribution | |
| 289510 | In distribution | |
| 289516 | In distribution | |
| 230058 | In distribution | |
| 269951 | In distribution | |
| 289634 | In distribution | |
| 289620 | In distribution | |
| 290672 | In distribution | |
| 279571 | In distribution | |
| 256389 | In distribution | |
| 289604 | In distribution | |
| 271202 | In distribution | |
| 269956 | In distribution | |
| 289534 | In distribution | |
| 279562 | In distribution | |
| 269941 | In distribution | |
| 276383 | In distribution | |
| 233667 | In distribution | |
| 276901 | In distribution | |
| 230056 | In distribution | |
| 247381 | In distribution | |
| 280492 | In distribution | |
| 240606 | In distribution | |
| 287655 | In distribution | |
| 229308 | In distribution | |
| 279550 | In distribution | |
| 242481 | In distribution | |
| 257364 | In distribution | |
| 279568 | In distribution | |
| 289605 | In distribution | |
| 293079 | In distribution | |
| 262923 | In distribution | |
| 279546 | In distribution | |
| 279545 | In distribution | |
| 293082 | In distribution | |
| 276898 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Oticon | Sbo Hearing A/S | 570 |
| Starkey | Starkey Laboratories, Inc. | 449 |
| Phonak | Sonova AG | 448 |
| Oticon | Oticon A/S | 353 |
| Nuear | Starkey Laboratories, Inc. | 336 |
| Audibel | Starkey Laboratories, Inc. | 318 |
| Unitron | Unitron Hearing Division | 292 |
| Audigy | Starkey Laboratories, Inc. | 284 |
| Microtech | Starkey Laboratories, Inc. | 284 |
| audifon | Audifon – Gmbh & Co.kg | 277 |
| Philips | Sbo Hearing A/S | 270 |
| Agxo | Sbo Hearing A/S | 260 |
Showing 12 of 86. All products under Masker, Tinnitus
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.