Welch Allyn 3.5 V Halogen HPX Retinoscope Set including Elite Streak Retinoscope (#18240), Fiber-Optic Finnoff Ocular Transilluminator (#41100), Rechargeable 60-Minute Power Handle(s) --…
Welch Allyn 3.5 V Halogen HPX Retinoscope Set including Elite Streak Retinoscope (#18240), Fiber-Optic Finnoff Ocular Transilluminator (#41100), Rechargeable 60-Minute Power Handle(s) — C-Cell Convertible, Soft Storage Case, Fixation Cards; Nickel-Cadmium (#72300) Battery; IEC Plug Type-A
Who Else Makes It
Concentrated in Jiangsu (5), Beijing (1), Shaanxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
Record
Regulatory record for Welch Allyn, Inc. | Listed by | Welch Allyn, Inc., United States |
| FDA product code | HKM |
| Device type | Retinoscope, Battery-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1780 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-08-17 |
| Record revised | 2025-03-26 (version 6) |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Supplied sterile | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2026-02-03 |
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.