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Sign in to claim this brandTranscendencias Comerciales SL Transcom
US
Last updated May 23, 2026
What Transcendencias Comerciales SL Transcom makes
Transcendencias Comerciales SL Transcom manufactures the HC-1 and HC-1 Classic devices, which are designed for [specific medical purpose implied by Class II designation, e.g., diagnostic or therapeutic use in a defined clinical area]. These products are intended for [brief functional context, e.g., patient monitoring, imaging, or minimally invasive procedures] as outlined in their regulatory submissions.
The HC-1 and HC-1 Classic are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearance records. The company is based in the United States, with these devices listed in the FDA’s regulatory database.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Transcendencias Comerciales SL Transcom manufacture?
Transcendencias Comerciales SL Transcom manufactures the HC-1 and HC-1 Classic devices. These products fall under the Class II category, which typically includes devices requiring special controls to ensure their safety and effectiveness for uses like diagnostic procedures, patient monitoring, or therapeutic interventions in specific clinical settings.
Where is Transcendencias Comerciales SL Transcom based?
The company is based in the United States. This location is relevant for regulatory compliance, as the devices are subject to FDA oversight and classification under U.S. medical device regulations.
Are Transcendencias Comerciales SL Transcom’s devices listed in any regulatory registries?
Yes, the HC-1 and HC-1 Classic devices are listed in the FDA’s 510(k) clearance registry. This registry documents that the devices meet the regulatory requirements for Class II devices, which require pre-market notification (510(k)) submissions to demonstrate substantial equivalence to a legally marketed predicate device.
How are Transcendencias Comerciales SL Transcom’s devices classified under FDA regulations?
The HC-1 and HC-1 Classic devices are classified as Class II medical devices. This classification indicates they pose moderate risk and require special controls beyond general controls (like good manufacturing practices) to ensure their safety and performance. The classification is determined by the FDA based on the device’s intended use and potential risks.
AI-generated from registry data and not verified by a human reviewer.
Information
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- US
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Catalogue (9)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Colonic Irrigation Kit | Segmented Hose / Hydrokit with limiter | FDA UDI | Class II | Active |
| Colonic Irrigation Kit | Hydrokit with limiter | FDA UDI | Class II | Active |
| Colonic Irrigation Kit | Segmented Hose / Large Hydrokit | FDA UDI | Class II | Active |
| Colonic Lavage Unit | HC-1 Classic | FDA UDI | Class II | Active |
| Colonic Lavage Unit | HC-1 | FDA UDI | Class II | Active |
| Colonic Irrigation Kit | Large Hydrokit | FDA UDI | Class II | Active |
| Colonic irrigation Kit | Small Hydrokit | FDA UDI | Class II | Active |
| Colonic Lavage Unit | HC-2000 Classic | FDA UDI | Class II | Active |
| Hc-1 And Hc-1 Classic | K131852 | FDA 510(k) | Class II | Active |
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