Permablate
Permablate Electrolysis Unit
1manufacturer
1catalogue number
Who Else Makes It
Registered in Guangdong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Ever Strong Manufacturing Ltd | Dongguan | Guangdong | Contract manufacturer | 8 |
Record
| Listed by | Gmmi SDN BHD, Malaysia |
|---|---|
| FDA product code | HPY |
| Device type | Unit, Electrolysis, Battery-Powered, Ophthalmic |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4250 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-11-13 |
| Record revised | 2020-12-21 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Carton of 32 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PEU-K01 | In distribution |
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.