Year 1 · AEDTH

MDR-01-04

Lost-core silicone vessel phantom

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Offered in year 1

Open the door. Invoice services and non-device models. No EDA device file yet.

Patent lumen phantom made by soluble core and platinum silicone, under the casting method in SOP-001.

  • Clear silicone arterial tree mounted on a transparent plate, from the feet to the head.

    A full-body arterial phantom: a lumen a device can track. Photograph from a silicone-simulator catalogue (Ningbo Trando). It shows the class of model AEDTH is building toward. It was not made at Smouha, and it is not a supplier selected for purchase.

  • A flat clear plate with a tortuous carotid path and a circle of vessels.

    A tortuous carotid path in a flat plate. This is the insert idea: one carrier, a lumen you can change. Photograph from a silicone-simulator catalogue (Ningbo Trando). It shows the class of model AEDTH is building toward. It was not made at Smouha, and it is not a supplier selected for purchase.

Regulatory posture
Not a medical device. For planning, rehearsal or training. Not for diagnosis or implantation.
Who it is for
Simulation unit and biomedical engineering
Kind
Phantom
Limit
Wall thickness and silicone grade are declared per batch. Not a certified test device.

What is in the line

  • Phantom
  • Batch record
  • Leak check at 150–200 mmHg