Pure Global
10887714032995

NuCLEUS

NuMED, Inc.·Class III·EU EUDAMED·Trade name: NuCLEUSNo
Device classification
Risk class
Class III
CND nomenclatures code
C019014
Trade name
NuCLEUS
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
10887714032995
Basic UDI
B-10887714032995
Version date
June 14, 2023
Manufacturer last update
August 02, 2021
Active status
No
Manufacturer
Manufacturer name
NuMED, Inc.
Country
United States
Country type
NON_EU
Address
2880 Main Street Hopkinton
Email
nlaflesh@numedusa.com
Authorized representative
Name
G. van Wageningen B.V.
SRN
NL-AR-000010437
Country
Netherlands
Address
40 Hallenweg Best
Email
quality@heartmedical.nl
Telephone
+31499377388
Regulatory information
Competent authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Belgium
Market available
Austria:1999-02-25~2024-02-25, Belgium:1999-02-25~2024-02-25, Bulgaria:1999-02-25~2024-02-25, Croatia:1999-02-25~2024-02-25, Cyprus:1999-02-25~2024-02-25, Czechia:1999-02-25~2024-02-25, Denmark:1999-02-25~2024-02-25, Estonia:1999-02-25~2024-02-25, Finland:1999-02-25~2024-02-25, France:1999-02-25~2024-02-25, Germany:1999-02-25~2024-02-25, Greece:1999-02-25~2024-02-25, Hungary:1999-02-25~2024-02-25, Iceland:1999-02-25~2024-02-25, Ireland:1999-02-25~2024-02-25, Italy:1999-02-25~2024-02-25, Latvia:1999-02-25~2024-02-25, Liechtenstein:1999-02-25~2024-02-25, Lithuania:1999-02-25~2024-02-25, Luxembourg:1999-02-25~2024-02-25, Malta:1999-02-25~2024-02-25, Netherlands:1999-02-25~2024-02-25, Norway:1999-02-25~2024-02-25, Poland:1999-02-25~2024-02-25, Portugal:1999-02-25~2024-02-25, Romania:1999-02-25~2024-02-25, Slovakia:1999-02-25~2024-02-25, Slovenia:1999-02-25~2024-02-25, Spain:1999-02-25~2024-02-25, Sweden:1999-02-25~2024-02-25, Turkey:1999-02-25~2024-02-25, United Kingdom (Northern Ireland only):1999-02-25~2024-02-25
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

CARDIAC VALVULOPLASTY CATHETERS

About this record

Access comprehensive regulatory information for NuCLEUS in the European Union medical device market through Pure Global AI's free database. This Class III device is registered with EU EUDAMED under Primary DI 10887714032995 and manufactured by NuMED, Inc. in United States.

This page provides complete registration details including trade name (NuCLEUS), 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.