EOS
fetal stethoscope
4manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Anhui (2), Jiangsu (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Hospital & Homecare IMP. & EXP. Co., Ltd. | Nanjing | Jiangsu | Contract manufacturer | 179 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
| Hefei Mlush Sanitary Products Co., Ltd. | Hefei | Anhui | Manufacturer | 48 |
Record
| Listed by | North EOS Industries, Inc., Taiwan |
|---|---|
| FDA product code | HGN |
| Device type | Stethoscope, Fetal |
| Device class | Class 1 |
| Regulation | 21 CFR 884.2900 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-11-30 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Distribution end date | 2018-11-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EosStethoscope | Withdrawn |
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.