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Norco Compression Gloves - EUDAMED Registration 00768627011709

Access comprehensive regulatory information for Norco Compression Gloves 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 00768627011709 and manufactured by North Coast Medical Inc. in United States.

This page provides complete registration details including trade name (Norco Compression Gloves), 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.

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EUDAMED Official Data
Class I
00768627011709
Yes
Norco Compression Gloves
Trade Name: Norco Compression Gloves
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Device Description (EMDN)

ELASTIC BANDAGES, SUPPORT AND COMPRESSION - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
M030499
Trade Name
Norco Compression Gloves
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00768627011709
Basic UDI
07686272054S7
Version Date
May 30, 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
Netherlands
Market Available
Austria:2022-12-16~2029-12-31, Belgium:2022-12-16~2029-12-31, Finland:2022-12-16~2029-12-31, France:2022-12-16~2029-12-31, Germany:2022-12-16~2029-12-31, Ireland:2022-12-16~2029-12-31, Liechtenstein:2022-12-16~2029-12-31, Luxembourg:2022-12-16~2029-12-31, Netherlands:2022-12-16~2029-12-31, Spain:2022-12-16~2029-12-31, Sweden:2022-12-16~2029-12-31, United Kingdom (Northern Ireland only):2022-12-16~2029-12-31
Device Characteristics
Human Tissues
No
Animal Tissues
No