Pure Global

Outie Tool - EUDAMED Registration 00894365002270

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 00894365002270 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class I
00894365002270
No
Outie Tool
Trade Name: Outie Tool
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

ORTHODONTIC DEVICES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q010499
Trade Name
Outie Tool
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00894365002270
Basic UDI
894365002OutieTool3Z
Version Date
June 17, 2024
Manufacturer Last Update
June 07, 2024
Active Status
No
Manufacturer
Manufacturer Name
Nadine & Co., LLC
Country
United States
Country Type
NON_EU
Address
10079 Pandora Dr La Mesa
Email
nadine@nadineandco.com
Authorized Representative
SRN
NL-AR-000037688
Country
Netherlands
Address
2b Lange Viestraat Utrecht
Email
eurep@casusconsulting.com
Regulatory Information
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
Device Characteristics
Human Tissues
No
Animal Tissues
No