1077 AccuScreen
1077 MADSEN AccuScreen, ABR/TE including standard accessories incl. probe
4manufacturers in China registered for this device type
1catalogue number
1recall
Who Else Makes It
Concentrated in Guangdong (2), Jiangsu (1), Shaanxi (1). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amphenol Medical Technologies (Dongguan) Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 77 |
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
| Dong Guan Danchen Electrical Products Ltd. | Dong Guan | Guangdong | Contract manufacturer | 2 |
| GE Medical Systems (China) Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 57 |
Record
| Listed by | Natus Medical Denmark ApS, Denmark |
|---|---|
| FDA product code | GWJ |
| Device type | Stimulator, Auditory, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1900 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Record published | 2021-04-26 |
| Record revised | 2025-10-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 8-04-13904 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| GN Otometrics A/S | Natus Medical Denmark ApS | 117 |
| Natus Medical | Natus Medical Incorporated | 25 |
| QScreen Set | Path | 24 |
| AccuScreen | Natus Medical Denmark ApS | 20 |
| Natus | Natus Medical Incorporated | 18 |
| Sentiero Advanced | Path | 14 |
| Algo Pro | Natus Medical Denmark ApS | 9 |
| Algo Pro | Xltek | 9 |
| Stimulator, Auditory, Evoked Response | Medtronic Xomed, Inc. | 7 |
| Algo 3i | Natus Medical Denmark ApS | 5 |
| Teoae probe tips | Otodynamics, Ltd. | 5 |
| Algo 5 | Natus Medical Denmark ApS | 5 |
Showing 12 of 305. All products under Stimulator, Auditory, Evoked Response
Recalls
1 of these is Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2019-05-28 | Class II | Device Design | There is a risk to the healthcare professional or patient of exposure to undergrounded electrical surfaces which may result in an electrical shock. | 3071 individual units | 2021-04-09 |
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.