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Sign in to claim this brandImagyn Medical Technologies, Inc.
US
Last updated May 23, 2026
What Imagyn Medical Technologies, Inc. makes
Imagyn Medical Technologies, Inc. manufactures a range of medical devices including the ECOM CV4 Endotracheal Cardiac Output Monitor, the ERECAID System/Stay Erec System, the IMPOWER External Vacuum System, the IMAGYN Isosleeve/Isostar Needle System, the IM2001 Pulse Oximeter, the Isostar I-125 Interstitial Seed, Model IS-12501, and the OAC (Optical Aspirating Curette).
The company's portfolio includes Class I and Class II devices, which are listed in the FDA 510(k) registry. Imagyn Medical Technologies is based in the US.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What type of products does Imagyn Medical Technologies, Inc. manufacture?
Imagyn Medical Technologies, Inc. manufactures a range of medical devices, including monitors, systems, and equipment for various medical applications, such as cardiac output monitoring and interstitial seed placement, as seen in devices like the ECOM CV4 and Isostar I-125.
Where is Imagyn Medical Technologies, Inc. based?
Imagyn Medical Technologies, Inc. is based in the US.
Which regulatory registries list Imagyn Medical Technologies, Inc.'s devices?
Imagyn Medical Technologies, Inc.'s devices are listed in the FDA 510(k) registry.
How are Imagyn Medical Technologies, Inc.'s devices classified?
Imagyn Medical Technologies, Inc.'s devices are classified as either Class I or Class II devices.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
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- PRRC Contact
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- EUDAMED SRN
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- DUNS Number
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Catalogue (8)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Imac2000 | K911764 | FDA 510(k) | Class II | Active |
| Ecom Cv4 Endotracheal Cardiac Output Monitor | K032491 | FDA 510(k) | Class II | Active |
| Erecaid System/Stay Erec System | K974173 | FDA 510(k) | Class II | Active |
| Impower External Vacuum System | K980291 | FDA 510(k) | Class II | Active |
| Imagyn Isosleeve / Isostar Needle System | K010166 | FDA 510(k) | Class I | Active |
| Im2001 Pulse Oximeter | K012706 | FDA 510(k) | Class II | Active |
| Isostar I-125 Interstitial Seed, Model Is-12501 | K991526 | FDA 510(k) | Class II | Active |
| Oac (optical Aspirating Curette) | K980096 | FDA 510(k) | Class I | Active |
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