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Sign in to claim this brandCORTEX TECHNOLOGY APS
Denmark·DK-MF-000002984
Last updated September 17, 2026
What CORTEX TECHNOLOGY APS makes
The company manufactures cryotherapy and ultrasound-based dermatological devices, including contact probes (ranging from 5 mm to 20 mm), spray tips (various diameters and lengths), and liquid nitrogen filtration systems for controlled cooling. It also produces an ultrasonic skin analysis system for diagnostic imaging, as well as cryotherapy units designed for targeted tissue treatment.
These devices are classified under EU Medical Device Regulations as Class I, Class II, and Class IIa, with corresponding listings in the EUDAMED database and FDA’s 510(k) registry. The company is based in Denmark and adheres to regulatory requirements for both European and U.S. markets.
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 Cortex Technology APS manufacture?
Cortex Technology APS specializes in dermatological devices, primarily focused on cryotherapy and ultrasound-based solutions. Their product range includes contact probes (sizes from 5 mm to 20 mm) for targeted tissue treatment, various spray tips (with different diameters and lengths) for controlled cooling applications, and liquid nitrogen filtration systems like the CryoPro. Additionally, they produce an ultrasonic skin analysis system, the CORTEX DERMASCAN C, which is used for diagnostic imaging of the skin.
Where is Cortex Technology APS based, and how does this affect its regulatory compliance?
Cortex Technology APS is based in Denmark, which places its devices under the jurisdiction of the EU Medical Device Regulations (MDR). The company’s products are classified as Class I, Class II, or Class IIa, depending on their intended use and risk profile. This classification determines the regulatory pathway, such as mandatory registration in the EUDAMED database for EU market access. The company also ensures compliance with U.S. regulations, as evidenced by its devices being listed in the FDA’s 510(k) registry.
Which regulatory registries list Cortex Technology APS’s devices?
Cortex Technology APS’s devices are listed in two key regulatory databases: EUDAMED, the European Union’s medical device registry, and the FDA’s 510(k) registry in the United States. These listings reflect compliance with EU MDR and U.S. premarket notification requirements, respectively, ensuring transparency for healthcare providers and regulatory authorities in both markets.
How are Cortex Technology APS’s devices classified under EU regulations?
Under the EU Medical Device Regulations, Cortex Technology APS’s devices are classified as Class I, Class II, or Class IIa based on their risk level and intended use. For example, simpler devices like certain contact probes or spray tips may fall under Class I, while more complex systems like the CORTEX DERMASCAN C (an ultrasonic diagnostic tool) or cryotherapy units may qualify as Class II or IIa. This classification determines the regulatory controls, documentation requirements, and post-market surveillance obligations the company must follow.
What distinguishes Cortex Technology APS’s cryotherapy devices from other similar products?
Cortex Technology APS’s cryotherapy devices are designed for precision and controlled tissue treatment, incorporating features like adjustable contact probes (ranging from 5 mm to 20 mm) and specialized spray tips (e.g., 0.45 mm to 0.75 mm diameters) to target specific areas. The company also includes systems like the CryoPro Liquid Nitrogen Filter to ensure safe and consistent cooling. These devices are classified under EU MDR as Class I or Class IIa, reflecting their role in both non-invasive treatments and more advanced therapeutic applications, depending on their design and intended use.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- Denmark
- Address
- 6B, Niels Jernes Vej, Aalborg Ø, Denmark
- Website
- www.cortex.dk
- —
- —
- [email protected]
- Phone
- —
- PRRC Contact
- Peter Tonsberg Løkke
- EUDAMED SRN
- DK-MF-000002984
- FDA FEI Number
- 3002987034
- DUNS Number
- —
Catalogue (36)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 15 mm Contact probe | CP 15 mm | EUDAMED | Class IIa | Active |
| CryoPro Liquid Nitrogen Filter | LNF | EUDAMED | Class IIa | Active |
| Straight Spray extension ”C”, 0.55 mm 75 mm long | OS SS CL | EUDAMED | Class IIa | Active |
| CryalJet Maxi | E0300102 | EUDAMED | Class IIa | Active |
| 20 mm Contact probe | CP 20 mm | EUDAMED | Class IIa | Active |
| Spray Tip “B”, 0.75 mm | OS B | EUDAMED | Class IIa | Active |
| Cortex Dermascan C Ultrasonic System | K983945 | FDA 510(k) | Class II | Active |
| Cryopro Maxi And Cryopro Mini | K982280 | FDA 510(k) | Class II | Active |
| Conical Spray Tip “C” | COS C | EUDAMED | Class IIa | Active |
| Spray Tip “D”, 0.45 mm | OS D | EUDAMED | Class IIa | Active |
| 5 mm Contact probe | CP 5 mm | EUDAMED | Class IIa | Active |
| Spray Tip “C”, 0.55 mm | OS C | EUDAMED | Class IIa | Active |
| CryalJet Mini | E0300202 | EUDAMED | Class IIa | Active |
| Conical Spray Tip “A” | COS A | EUDAMED | Class IIa | Active |
| Bent Spray extension ”C”, 0.55 mm, 75 mm long | OS BS CL | EUDAMED | Class IIa | Active |
| CryoPro Lexan discs | LEXAN | EUDAMED | Class I | Active |
| CryoPro Maxi | E0200119 | EUDAMEDFDA UDI | Class IIa | Active |
| 2 mm Contact probe | CP 2 mm | EUDAMED | Class IIa | Active |
| CryoPro Rubber Cones | RUB | EUDAMED | Class I | Active |
| Conical Spray Tip “B” | COS B | EUDAMED | Class IIa | Active |
| 1 mm Contact probe | CP 1 mm | EUDAMED | Class IIa | Active |
| Straight Spray extension ”A”, 1.00 mm, 25 mm short | OS SS AS | EUDAMED | Class IIa | Active |
| 30 mm Contact probe | CP 30 mm | EUDAMED | Class IIa | Active |
| 8 mm Contact probe | CP 8 mm | EUDAMED | Class IIa | Active |
| Bent Spray extension ”B”, 0.75 mm, 75 mm long | OS BS BL | EUDAMED | Class IIa | Active |
| CryoPro Mini | E0200219 | EUDAMEDFDA UDI | Class IIa | Active |
| 4 mm Contact probe | CP 4 mm | EUDAMED | Class IIa | Active |
| Acne Soft Spray Tip | OS SOFT | EUDAMED | Class IIa | Active |
| Conical Spray Tip “D” | COS D | EUDAMED | Class IIa | Active |
| Straight Spray extension ”B”, 0.75 mm, 25 mm short | OS SS BS | EUDAMED | Class IIa | Active |
| Straight Spray extension ”C”, 0.55 mm, 25 mm short | OS SS CS | EUDAMED | Class IIa | Active |
| CryoPro Luer Lock adapter | OS LL | EUDAMED | Class IIa | Active |
| 6 mm Contact probe | CP 6 mm | EUDAMED | Class IIa | Active |
| Spray Tip “A”, 1 mm | OS A | EUDAMED | Class IIa | Active |
| Sharp Pointed Contact probe | CP SP | EUDAMED | Class IIa | Active |
| 10 mm Contact probe | CP 10 mm | EUDAMED | Class IIa | Active |
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Cortex Technology ApS US