Outie Tool
- Risk class
- Class I
- CND nomenclatures code
- Q010499
- Trade name
- Outie Tool
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 00894365002119
- Basic UDI
- 894365002OutieTool3Z
- Version date
- June 19, 2024
- Manufacturer last update
- June 07, 2024
- Active status
- No
- Manufacturer name
- Nadine & Co., LLC
- Country
- United States
- Country type
- NON_EU
- Address
- 10079 Pandora Dr La Mesa
- nadine@nadineandco.com
- SRN
- NL-AR-000037688
- Country
- Netherlands
- Address
- 2b Lange Viestraat Utrecht
- eurep@casusconsulting.com
- Competent authority
- Ministerie van Volksgezondheid, Welzijn en Sport
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- Finland
- Market available
- Denmark:None~None, Finland:None~None, France:None~None, Germany:None~None, Italy:None~None
- Human tissues
- No
- Animal tissues
- No
ORTHODONTIC DEVICES - OTHER
Access comprehensive regulatory information for Outie Tool in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 00894365002119 and manufactured by Nadine & Co., LLC in United States.
This page provides complete registration details including trade name (Outie Tool), manufacturer information, authorized representative details, competent authority (Ministerie van Volksgezondheid, Welzijn en Sport), and regulatory compliance data from the official EU EUDAMED medical device database. Pure Global AI offers free access to the European Union's complete medical device registry, helping global MedTech companies navigate EU MDR regulations efficiently.