Dot Incorporation
Active in EUDAMEDSouth Koreafrom SRN EUDAMED SRN KR-MF-000043120
- Devices
- 2
- Registrations
- EUDAMED
At a glance
Market reach
- European Union
- EUDAMED actor
- Authorised rep.
- Grambly GmbHDE
Catalogue
Company details
- EUDAMED SRN
- KR-MF-000043120
- EU VAT number
- 327-87-00041
- EUDAMED status
- Active
- EUDAMED registered name
- Dot Incorporation
- EUDAMED abbreviated name
- DOT
- Registered address
- Geumcheon-gu, Suite 401~405, 146, Gasan digital 1-ro, 08507, Seoul, South Korea
- Website
- www.dotincorp.com
- [email protected]
- Phone
- +82 2 864 1113
- PRRC contact
- Boram Yoon
What Dot Incorporation makes
Dot Incorporation manufactures the Dot Pad, a reusable, single-use disposable medical device designed for wound care and skin protection. The product is intended for use in clinical settings to provide a sterile barrier over wounds or sensitive skin areas, reducing contamination risk during procedures.
The Dot Pad is classified as a Class I medical device under EU regulations and is registered in the EUDAMED database. The company is based in South Korea and adheres to relevant regulatory standards for its listed devices.
Frequently asked questions
How many devices does Dot Incorporation have in the registry?
The registry currently lists 2 devices for Dot Incorporation. Devices recorded under merged duplicate company entries are counted once.
Which registries list Dot Incorporation's devices?
Among its 2 most recently registered devices, Dot Incorporation has devices listed in EUDAMED (2 devices).
What risk classes do Dot Incorporation's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Dot Incorporation's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Dot Incorporation in the registry?
The most recently registered devices listed for Dot Incorporation include Dot Pad.