PainChek® Adult is a certified Class I medical device, with CE Marking and TGA Australian Register of Therapeutic Goods (ARTG) inclusion.
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Item |
Symbol |
Details |
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Manufacturer |
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PainChek Ltd Suite 401, 35 Lime Street Sydney NSW 2000 AUSTRALIA |
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Australian Sponsor |
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PainChek Ltd Suit 401, 35 Lime Street Sydney NSW 2000 AUSTRALIA |
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European Union Representative |
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Donawa Lifescience Ltd Piazza Albania, 10 00153 Rome ITALY |
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Device Identifier |
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PainChek® Resident |
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Year of manufacture |
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2023 |
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Serial Number |
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Refer to the product version number displayed in PainChek® App or the PainChek® Portal |
PainChek® Adult is a regulated medical device requiring pre-market clearance under the Federal Food, Drug & Cosmetic Act. The device is currently under clinical investigation and has not been cleared or approved by the FDA for safety and effectiveness.