Oticon

Oticon Verit Demoflex Minibte T 85 C090

Registry build 21.09.26
4manufacturers in China registered for this device type
570catalogue 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.

Chinese manufacturers registered for FDA product code KLW
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

Regulatory record for Oticon
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 2022-08-10
Record revised 2025-03-24 (version 5)

Specifications

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 numbers for Oticon
Catalogue number Size Status
255257 In distribution
289478 In distribution
235697 In distribution
276435 In distribution
255954 In distribution
245351 In distribution
247959 In distribution
235679 In distribution
249252 In distribution
269597 In distribution
248579 In distribution
255928 In distribution
279508 In distribution
279496 In distribution
279495 In distribution
248466 In distribution
248190 In distribution
290617 In distribution
235691 In distribution
241192 In distribution
276298 In distribution
276437 In distribution
270160 In distribution
286098 In distribution
290625 In distribution
228985 In distribution
276654 In distribution
220335 In distribution
289474 In distribution
269582 In distribution
234161 In distribution
241198 In distribution
259449 In distribution
241195 In distribution
269584 In distribution
289437 In distribution
228984 In distribution
235714 In distribution
251727 In distribution
262899 In distribution
269596 In distribution
269603 In distribution
248193 In distribution
276657 In distribution
269618 In distribution
235668 In distribution
270562 In distribution
235682 In distribution
235670 In distribution
234176 In distribution
248182 In distribution
248622 In distribution
289485 In distribution
235688 In distribution
240495 In distribution
274919 In distribution
279507 In distribution
276302 In distribution
255953 In distribution
228986 In distribution
247369 In distribution
279278 In distribution
270128 In distribution
270559 In distribution
255949 In distribution
284180 In distribution
240192 In distribution
247963 In distribution
289404 In distribution
236769 In distribution
248624 In distribution
248165 In distribution
248611 In distribution
286150 In distribution
250603 In distribution
248470 In distribution
250448 In distribution
289432 In distribution
268431 In distribution
270155 In distribution
289420 In distribution
250387 In distribution
247231 In distribution
250600 In distribution
270527 In distribution
259469 In distribution
248458 In distribution
289479 In distribution
247299 In distribution
257003 In distribution
247970 In distribution
258494 In distribution
250446 In distribution
289445 In distribution
245353 In distribution
250608 In distribution
248180 In distribution
279280 In distribution
235675 In distribution
269579 In distribution
275797 In distribution
258487 In distribution
285043 In distribution
255947 In distribution
289477 In distribution
290614 In distribution
262885 In distribution
255277 In distribution
286087 In distribution
276884 In distribution
279310 In distribution
268465 In distribution
250453 In distribution
230997 In distribution
290618 In distribution
276888 In distribution
219642 In distribution
292908 In distribution
241153 In distribution
270171 In distribution
289486 In distribution
289490 In distribution
262877 In distribution
247967 In distribution
292999 In distribution
250390 In distribution
255946 In distribution
274956 In distribution
255281 In distribution
247750 In distribution
255264 In distribution
286169 In distribution
250454 In distribution
289454 In distribution
287653 In distribution
289468 In distribution
289496 In distribution
289434 In distribution
228981 In distribution
286160 In distribution
235687 In distribution
250394 In distribution
289467 In distribution
236787 In distribution
229196 In distribution
248594 In distribution
270172 In distribution
248152 In distribution
240490 In distribution
290610 In distribution
251728 In distribution
236834 In distribution
269621 In distribution
248158 In distribution
248460 In distribution
270145 In distribution
247271 In distribution
247976 In distribution
234170 In distribution
247230 In distribution
248178 In distribution
251724 In distribution
229197 In distribution
229203 In distribution
259442 In distribution
248200 In distribution
259445 In distribution
270152 In distribution
247754 In distribution
276306 In distribution
257027 In distribution
229201 In distribution
250450 In distribution
285636 In distribution
290628 In distribution
289435 In distribution
248157 In distribution
248195 In distribution
257009 In distribution
279521 In distribution
270170 In distribution
289403 In distribution
248602 In distribution
279500 In distribution
228209 In distribution
228208 In distribution
235703 In distribution
257337 In distribution
276890 In distribution
235686 In distribution
262886 In distribution
270142 In distribution
245367 In distribution
276662 In distribution
235704 In distribution
248597 In distribution
282113 In distribution
248187 In distribution
270493 In distribution
276545 In distribution
240189 In distribution
265702 In distribution
255931 In distribution
255958 In distribution
292907 In distribution
258473 In distribution
234166 In distribution
255943 In distribution
262901 In distribution
269592 In distribution
290605 In distribution
235705 In distribution
234185 In distribution
289406 In distribution
289449 In distribution
248198 In distribution
285090 In distribution
255254 In distribution
249254 In distribution
255939 In distribution
248176 In distribution
289473 In distribution
270131 In distribution
250797 In distribution
259459 In distribution
250388 In distribution
248620 In distribution
235711 In distribution
220336 In distribution
289460 In distribution
247366 In distribution
289412 In distribution
255935 In distribution
234171 In distribution
259454 In distribution
234155 In distribution
268434 In distribution
286069 In distribution
240183 In distribution
248153 In distribution
248461 In distribution
245365 In distribution
234154 In distribution
271197 In distribution
248583 In distribution
255278 In distribution
279518 In distribution
245334 In distribution
276886 In distribution
248588 In distribution

Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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
Hansaton Hansaton Akustik GmbH 249

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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer