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INNO Int. Fixture - EUDAMED Registration 08800016103915

Access comprehensive regulatory information for INNO Int. Fixture 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 08800016103915 and manufactured by Cowellmedi Co., Ltd. in Republic of Korea.

This page provides complete registration details including trade name (INNO Implant System), 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.

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EUDAMED Official Data
Class IIb
08800016103915
No
INNO Int. Fixture
Trade Name: INNO Implant System
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Device Description (EMDN)

DENTAL IMPLANTS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P01020101
Trade Name
INNO Implant System
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08800016103915
Basic UDI
B-08800016103915
Version Date
August 06, 2024
Manufacturer Last Update
May 20, 2024
Active Status
No
Manufacturer
Manufacturer Name
Cowellmedi Co., Ltd.
Country
Republic of Korea
Country Type
NON_EU
Address
48 Hakgam-daero 221beon-gil Busan
Email
osj@cowellmedi.co.kr
Authorized Representative
SRN
NL-AR-000023989
Country
Netherlands
Address
7 Amerlandseweg Breukelen
Email
info@ar-experts.eu
Telephone
+31889951333
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Netherlands
Market Available
Netherlands:2024-01-01~None
Device Characteristics
Human Tissues
No
Animal Tissues
No