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The Insides Neo - EUDAMED Registration 09421905447225

Access comprehensive regulatory information for The Insides Neo in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 09421905447225 and manufactured by The Insides Company Limited in New Zealand.

This page provides complete registration details including trade name (The Insides Neo), 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 IIa
09421905447225
No
The Insides Neo
Trade Name: The Insides Neo
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Device Description (EMDN)

GASTROINTESTINAL DEVICES - OTHER

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
G99
Trade Name
The Insides Neo
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
09421905447225
Basic UDI
09421905447CHYMEIIJL
Active Status
No
Manufacturer
Country
New Zealand
Country Type
NON_EU
Address
487 Parnell Road Auckland
Email
tina.mason@theinsides.co
Authorized Representative
SRN
MT-AR-000000234
Country
Malta
Address
Tower Street Swatar
Email
prrc@advena.mt
Regulatory Information
Competent Authority
Malta Medicines Authority
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Italy
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No