The Insides System - EUDAMED Registration 09421905447034
Access comprehensive regulatory information for The Insides System in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 09421905447034 and manufactured by The Insides Company Limited in New Zealand.
This page provides complete registration details including manufacturer information, authorized representative details, competent authority (Malta Medicines Authority), 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.
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EUDAMED Official Data
Class IIb
09421905447034
Yes
The Insides System
EU EUDAMED Registered Medical Device
Device Description (EMDN)
GASTROINTESTINAL DEVICES - OTHER
Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
G99
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
09421905447034
Basic UDI
B-09421905447034
Version Date
October 16, 2024
Manufacturer Last Update
April 27, 2023
Active Status
Yes
Manufacturer
Manufacturer Name
The Insides Company LimitedCountry
New Zealand
Country Type
NON_EU
Address
487 Parnell Road Auckland
Email
tina.mason@theinsides.co
Authorized Representative
Regulatory Information
Competent Authority
Malta Medicines Authority
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
United Kingdom (Northern Ireland only)
Market Available
Austria:2020-02-01~None, Belgium:2024-02-01~None, Croatia:2023-06-30~None, Czechia:2023-10-17~None, Denmark:2020-02-01~None, Estonia:2020-02-01~None, Finland:2024-06-01~None, France:2020-05-08~None, Germany:2020-02-01~None, Ireland:2020-02-01~None, Italy:2021-11-27~None, Netherlands:2020-02-01~None, Norway:2020-02-01~None, Portugal:2022-02-22~None, Slovenia:2020-02-01~None, Spain:2022-03-02~None, Sweden:2020-02-01~None, United Kingdom (Northern Ireland only):2020-02-01~None
Device Characteristics
Human Tissues
No
Animal Tissues
No

