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Sign in to claim this brandWhat Galemed Corp. makes
Galemed Corp. manufactures reusable and single-use respiratory devices, including electric transport ventilators, reusable anaesthesia face masks, and reusable PEEP valves. Their portfolio also covers ventilator supplemental circuits, reusable nasopharyngeal airways, and heated respiratory humidifiers, alongside laryngectomy tubes and disposable connectors. The company produces ventilator systems designed for both invasive and non-invasive mechanical ventilation, as well as accessories for airway management and humidification.
The company’s devices are regulated under FDA pathways, with products authorised through 510(k) clearances and the UDI program. Their portfolio spans Class I and Class II devices, reflecting a mix of lower-risk accessories and higher-risk active medical devices. All listed products comply with US regulatory requirements and are tracked in the FDA’s 510(k) and UDI registries.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
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- US
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- EUDAMED SRN
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Catalogue (27)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Babi.Plus | BC01-HD | FDA UDI | Class II | Active |
| Durable Straight Connector 7.6M, 4.3F barb | S0050F | EUDAMEDFDA UDI | Class I | Active |
| galemed | 38023 | EUDAMEDFDA UDI | Class I | Active |
| Sil.Plus | B121 | EUDAMEDFDA UDI | Class I | Active |
| Babi.Plus | BC01-AU | FDA UDI | Class II | Unknown |
| TC Pad 10 mm | DP01 | FDA UDI | Class I | Active |
| Jitto | GB10 | FDA UDI | Class II | Active |
| galemed | SP01 | FDA UDI | Class I | Active |
| galemed | 3431 | FDA UDI | Class II | Active |
| Jitto | GB30 | FDA UDI | Class II | Active |
| Venti.Plus | H025-M | FDA UDI | Class II | Active |
| Babi.Plus | BC23-HD | FDA UDI | Class II | Active |
| Galemed | 8581G | FDA UDI | Class I | Active |
| Sil.Flex | DP00 | FDA UDI | Class I | Active |
| galemed | SP02 | FDA UDI | Class I | Unknown |
| galemed | SP03 | FDA UDI | Class I | Active |
| Venti.Plus | H100-M | FDA UDI | Class II | Active |
| Jitto | GB20 | FDA UDI | Class II | Active |
| Jitto | GB30 | FDA UDI | Class II | Active |
| Jitto | GB30 | FDA UDI | Class II | Unknown |
| Jitto | GB40 | FDA UDI | Class II | Active |
| Babi.Plus | PA01 | FDA UDI | Class II | Active |
| Gio Digital Pressure Guages | K122627 | FDA 510(k) | Class II | Active |
| Af Viral/Bacterial Filter, Bf Viral/Bacterial Filter | K132679 | FDA 510(k) | Class II | Active |
| Dispo-Bag Manual Resuscitator, Disposable Adjustable Peep Valve, Disposable Fixed Peep Valve | K082092 | FDA 510(k) | Class II | Active |
| Disposable Adjustable Peep Valve Mr Conditional Use | K133957 | FDA 510(k) | Class II | Active |
| Galemed Peak Flow Meter, Models 3751/3752 | K022124 | FDA 510(k) | Class II | Active |
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