Pure Global

Casting Accessories - EUDAMED Registration 00768627010856

Access comprehensive regulatory information for Casting Accessories 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 00768627010856 and manufactured by North Coast Medical Inc. in United States.

This page provides complete registration details including trade name (Alpha), manufacturer information, authorized representative details, competent authority (Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ), 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
00768627010856
Yes
Casting Accessories
Trade Name: Alpha
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

IMMOBILISATION SYSTEMS AND DEVICES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
M030599
Trade Name
Alpha
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00768627010856
Basic UDI
0768627CASTACCY3
Version Date
May 26, 2023
Manufacturer Last Update
May 04, 2023
Active Status
Yes
Manufacturer
Manufacturer Name
North Coast Medical Inc.
Country
United States
Country Type
NON_EU
Address
Suite #110 135 E. Main St Morgan Hill
Email
quality@ncmedical.com
Authorized Representative
SRN
IE-AR-000006507
Country
Ireland
Address
South County Business Park Leopardstown, Dublin 18
Email
IconAR@iconplc.com
Telephone
+ 353 (1) 291 2000
Regulatory Information
Competent Authority
Agence Nationale de Sรฉcuritรฉ du Mรฉdicament et des Produits de Santรฉ
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Austria:2007-09-10~2029-12-31, Belgium:2007-09-10~2029-12-31, Finland:2007-09-10~2029-12-31, France:2007-09-10~2029-12-31, Germany:2007-09-10~2029-12-31, Luxembourg:2007-09-10~2029-12-31, Netherlands:2007-09-10~2029-12-31, Portugal:2007-09-10~2029-12-31, Sweden:2007-09-10~2029-12-31, United Kingdom (Northern Ireland only):2007-09-10~2029-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No