Free AI tool · No signupFree Denmark medical device classification tool
Describe your device and get a preliminary DKMA risk class, a clear explanation, official source links, and similar registered products where available.
Free · no loginStructured outputOfficial source linksRegistry evidence where available
Describe your device
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Tell us what the device does, who uses it, how it contacts the body, and whether it is powered, implantable, sterile, measuring, software, or an IVD.
Preliminary informational result — not an official regulatory decision.0 / 5,000
About this classifier
What the Denmark classifier checks
The classifier compares your product description with current DKMA classification requirements. It then gives you a suggested class, explains why it may apply, and shows the source links and product examples behind the result.
- How are medical devices classified in Denmark?
- DKMA uses a risk-based framework. Possible classes include Class I, Class Is, Class Im, Class Ir, Class IIa, Class IIb, Class III. National projection of the directly applicable EU MDR classification. The canonical class axis and rules are maintained in eu:medical-device; national references describe only administration or local deltas. The applicable class depends on the product's intended purpose, duration of use, invasiveness, active functions, implantability, sterility, software role, and other market-specific rules.
- What information does the Denmark classifier use?
- Current official DKMA classification requirements. Your result includes an explanation and links to the official sources used.
- Is the result an official DKMA classification decision?
- No. The result is a preliminary estimate based on the product details you provide and the information available. Confirm the classification with the applicable authority or a qualified regulatory professional before filing.
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