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Sign in to claim this brandChalgren Enterprises, Inc.
US
Last updated May 23, 2026
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Catalogue (132)
Page 3 of 3| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Chalgren | 266-9T-36STP | FDA UDI | Class II | Active |
| Chalgren | 112-812-48BTP | FDA UDI | Class II | Active |
| Chalgren | 293-2SL-36STP | FDA UDI | Class II | Active |
| Chalgren | 111-4125-24TP | FDA UDI | Class II | Active |
| Chalgren | 444-10S-72TP | FDA UDI | Class II | Active |
| Chalgren | 285-32-24TP | FDA UDI | Class II | Active |
| Chalgren | 445-10S-120TP | FDA UDI | Class II | Active |
| Chalgren | 221-28SS-375 | FDA UDI | Class II | Active |
| Chalgren | 125-425-36TP | FDA UDI | Class II | Active |
| Chalgren | 221-222SS-550-1 | FDA UDI | Class II | Active |
| Chalgren | 221-18SS-550 | FDA UDI | Class II | Active |
| Disp. Concentric Needle Electrode (dcp-30, Dcp-45) | K896370 | FDA 510(k) | Class II | Active |
| Disposable Concentric Needle Electrode | K931029 | FDA 510(k) | Class II | Active |
| Emg Recording Ring Electrode | K953356 | FDA 510(k) | Class II | Active |
| Emg Disc Recording Electrode | K953361 | FDA 510(k) | Class II | Active |
| 32mm Nickel Plated Disc Electrode | K953220 | FDA 510(k) | Class II | Active |
| Disposable Monopolar Needle Electrode, Var Models | K912282 | FDA 510(k) | Class II | Active |
| Fine Wire Electrode Mmodel Numbers 221-14-730, 221-24-730, 221-14-550, 221-24-550 | K982950 | FDA 510(k) | Class II | Active |
| Emg Disc Recording Electrode With Pin | K952690 | FDA 510(k) | Class II | Active |
| Re-Usable Bipolar Concentric Needle(237-Xxx-24, 237-Xxx-24stp, 237-Xxx-24tp, 237-Xxx-24stp | K960591 | FDA 510(k) | Class II | Active |
| Emg Disc Recording Electrode | K953354 | FDA 510(k) | Class II | Active |
| Reusable Dual Disc Bar Recording Electrodes | K923665 | FDA 510(k) | Class II | Active |
| Reusable Dual Disc Bar Electrodes, Various Models | K921504 | FDA 510(k) | Class II | Active |
| Disposable Hypodermic Monopolar Needle Recording Electrode | K955335 | FDA 510(k) | Class II | Active |
| Re-Usable Concentric Needle | K953887 | FDA 510(k) | Class II | Active |
| Reusable Finger Clip Recording Electrode | K925706 | FDA 510(k) | Class II | Active |
| 22mm Stainless Steel Disc Electrode, With Pin | K953219 | FDA 510(k) | Class II | Active |
| Emg Disc Recording Electrode With Pin | K952908 | FDA 510(k) | Class II | Active |
| Detachable, Disposable Monopolar Needle Electrode | K912283 | FDA 510(k) | Class II | Active |
| Disposable Concentric Needle Electrode | K924521 | FDA 510(k) | Class II | Active |
| Re-Usable Monopolar Needle | K953886 | FDA 510(k) | Class II | Active |
| Disposable Hypodermic Monoplar Needle Recording | K924277 | FDA 510(k) | Class II | Active |
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FDA Recalls (1)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Apr 12, 2007 | Z-2446-2010 | — | terminated | Sterility Compromised-- Investigation found that individual packaging seals were separating, which may compromise sterility. |