MedCenter 5000 Wall Mounted Set F.O./E56, US
Catalogue number 02.85020.002, listed by Kirchner & Wilhelm GmbH + Co.KG, Germany, under Aid, Vision, Optical, Ac-Powered. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shaanxi (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) | Taiyuan | Shaanxi | Contract manufacturer | 14 |
| Wenzhou Topsight Eyewear Co., Ltd. | Wenzhou | Zhejiang | Manufacturer | 5 |
Record
| Listed by | Kirchner & Wilhelm GmbH + Co.KG, Germany |
|---|---|
| FDA product code | HPI |
| Device type | Aid, Vision, Optical, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.5915 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-09-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 02.85020.002 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MedCenter 5000 wall mounted set, ear funnels module | Kirchner & Wilhelm GmbH + Co.KG | 1 |
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.