Maico

Aligo XT 9 FW 1.0.0

Registry build 21.09.26
4manufacturers in China registered for this device type
12catalogue 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 Maico
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 2023-02-10

Specifications

Specifications
MRI safety MR Unsafe
Prescription Prescription only
Label carries lot or batch number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Maico
Catalogue number Size Status
255354 In distribution
275003 In distribution
286091 In distribution
255356 In distribution
277085 In distribution
246141 In distribution
246202 In distribution
275004 In distribution
268483 In distribution
246140 In distribution
246203 In distribution
246204 In distribution

Same Product Code

Other products under the same FDA 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.

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