UDI CompassSnapshot 2026-10-25 · Link to EUDAMED
Accutome Inc. DBA Keeler USA
SRN US-MF-000036181
manufacturer · Malvern, US · 19 devices
3222 Phoenixville Pike, 19355
Devices
| Name | UDI-DI | Class | Badge |
|---|---|---|---|
| 18mm Immersion Scleral Shell, UBM | 00897826002413 | Class IIa | No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED |
| 20mm Immersion Scleral Shell, UBM | 00897826002420 | Class IIa | No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED |
| 22mm Immersion Scleral Shell, UBM | 00897826002437 | Class IIa | No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED |
| 4Sight | 00897826002079 | Class IIa | No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED |
| AccuPen | 00897826002000 | Class IIa | No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED |
| AccuTip Covers, 100/bx, individually wrapped | 00897826002086 | Class IIa | No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED |
| AccuTip Covers, 100 sleeved bulk bag | 00897826002109 | Class IIa | No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED |
| AccuTip Covers, 300/bx, individually wrapped | 00897826002093 | Class IIa | No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED |
| AccuTip Covers, 600/bx, bulk | 00897826002116 | Class IIa | No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED |
| A-Scan Plus Connect | 00897826002024 | Class IIa | No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED |
| A-Scan Probe | 00897826002321 | Class IIa | No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED |
| A-Scan Probe 4SIGHT | 00897826002307 | Class IIa | No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED |
| B-Scan Plus | 00897826002031 | Class IIa | No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED |
| B-Scan Probe 4SIGHT | 00897826002123 | Class IIa | No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED |
| Immersion Shell (Standard) | 00897826002222 | Class IIa | No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED |
| PachPen | 00897826002017 | Class IIa | No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED |
| Pachymeter Probe 4SIGHT | 00897826002345 | Class IIa | No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED |
| UBM Plus Guarded | 00897826002352 | Class IIa | No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED |
| UBM Probe 4SIGHT | 00897826002314 | Class IIa | No Certificate Found Snapshot 2026-10-25 · Link to EUDAMED |