Phoropter Arm
2 catalogue numbers from PA-3000, listed by MDT SP. Z O.O., Poland, under Stand, Instrument, Ophthalmic, Non-Powered. 1 manufacturer in China is registered for this product code.
1manufacturer
2catalogue numbers in this listing
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | MDT SP. Z O.O., Poland |
|---|---|
| FDA product code | HMG |
| Device type | Stand, Instrument, Ophthalmic, Non-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1860 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-07-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PA-3000 | In distribution | |
| PA-1000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ophthalmic Stool | MDT SP. Z O.O. | 4 |
| Stand, Instrument, Ophthalmic, Non-Powered | Konan Medical USA, Inc. | 1 |
| VistaView Slit Lamp Adapter | Volk Optical Inc. | 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.