Holland Healthcare’s newest telehealth device and intraoral, TelScope Telehealth System, is now registered as a Class 1 Medical Device with the FDA, registered with the TGA, and is CE Marked.
The United States Food and Drug Administration (FDA) classifies Class 1 Medical Devices as devices with low or moderate risk to patient safety. TelScope Telehealth System is registered with the FDA as a system, meaning that both the TelScope device and the TelScope App are registered with the FDA.
The Australian Therapeutic Goods Administration (TGA) is Australia’s governing body for therapeutic goods, including medical devices, in Australia. TelScope Telehealth System is registered with the TGA as a system. Once again, this means that both the TelScope device and the TelScope App are registered with the TGA.
Finally, TelScope is now CE Marked. The Certification Mark indicates that “conformity with health, safety, and environmental protection standards for products sold within the European Economic Area (EEA). The CE marking is also found on products sold outside the EEA that have been manufactured to EEA standards.” As with the FDA and TGA, TelScope Telehealth System is CE Marked as a system, meaning both the TelScope device and the TelScope App are CE Marked as per the EEA.
It is important to remember that the TelScope Throat Scope single-use depressors are registered for single-use only by the FDA. Throat Scope depressors attach to the TelScope Telehealth System as an illuminating tongue depressor to complete an oral telehealth exam. The Throat Scope single-use depressors are designed to reduce risk of cross-contamination. They come individually-wrapped, and they should not be cleaned and reused. The single-use depressors are recyclable, so we encourage you to recycle them after use. ♻️
To preorder TelScope Telehealth System, click here.
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