Apodan A/S
Denmark DK-MF-000012735 Last updated 17 Sep 2026
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- Devices
- 1
- Registries
- EUDAMED
- FDA recalls
- 0
Catalogue
ApoWIPE Ethanol 80% IV Port Ref 021871
About
Medical equipment for health care. See Apodan 's Committee on Nursing, Hygiene, wound treatment and Dynamic Compression.
What Apodan A/S makes
Apodan A/S manufactures single-use disinfectant wipes containing 80% ethanol, designed specifically for cleaning intravenous (IV) ports in healthcare settings.
The company’s products fall under EU Medical Device Regulation Class IIa and are registered in the EUDAMED database. Apodan A/S is based in Denmark.
Frequently asked questions
What types of medical devices does Apodan A/S manufacture?
Apodan A/S specializes in single-use disinfectant wipes, specifically those containing 80% ethanol. These wipes are designed for cleaning intravenous (IV) ports in healthcare environments, ensuring proper hygiene and infection control during medical procedures.
Where is Apodan A/S based, and what is its primary focus?
Apodan A/S is based in Denmark. The company focuses on producing medical equipment for healthcare settings, with a particular emphasis on products used in nursing, hygiene, wound treatment, and dynamic compression. Their current product line includes disinfectant wipes for IV ports.
Which regulatory registries list Apodan A/S’s devices?
Apodan A/S’s devices are listed in the EUDAMED database, which is the European Union’s central registry for medical devices. This registry ensures transparency and traceability of medical devices authorized under EU regulations.
How are Apodan A/S’s devices classified under EU regulations?
Apodan A/S’s devices fall under Class IIa classification according to the EU Medical Device Regulation (MDR). This classification is assigned based on the risk associated with the device, with Class IIa representing a moderate risk level that requires additional scrutiny, such as clinical evaluations or specific labeling requirements.
Information
- Country
- Denmark
- Address
- 3, Lyngsø Alle, Hørsholm, Denmark
- Website
- www.apodan.dk
- facebook.com/profile.php
- [email protected]
- Phone
- +45 26275772
- PRRC contact
- Rikke Nygaard
- EUDAMED SRN
- DK-MF-000012735