Isen Tech.&Trading Co., Ltd.
Manufacturer and brand owner in Beijing, China. 2 device types, 1 product catalogued, 1 clearance.
Isen Tech.&Trading Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Nystagmograph, Stimulator, Caloric-Air. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2017.
2device types registered with the FDA
1product
1510(k) clearance
Registration
| Registered name | ISEN TECH.&TRADING CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3011522961 |
| FEI number | 3011522961 |
| DUNS | 527141254 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 北京爱生科贸有限公司 |
|---|---|
| Source | export sales certificate, Beijing medical products administration |
Location
| City | Beijing |
|---|---|
| Province | Beijing |
| Address | 3 Gaoli Zhang Road |
| Postal code | 100095 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Nystagmograph | Class 2 | IG Pro, IG | 2017 | 3 |
| Stimulator, Caloric-Air | Class 1 | AirC | 2018 | 1 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| ISEN-Goggles | GWN | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K152727 | 2016-04-26 | GWN | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1991 |
|---|---|
| Main products | Balance assessment equipment, Hearing assessment systems, Auditory evoked potential instruments |
| Certifications | Medical device production and business licenses, High-tech enterprise certificates |
| Export markets | USA, Australia, 32 provincial administrative areas in China |
Nearby Manufacturers
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.
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