Pure Global
10884117002723

Z-5 Atrioseptostomy Catheter

NuMED Canada, Inc.·Class III·EU EUDAMED·Trade name: Z-5 AtrioseptostomyNo
Device classification
Risk class
Class III
CND nomenclatures code
C0199
Trade name
Z-5 Atrioseptostomy
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
10884117002723
Basic UDI
B-10884117002723
Version date
June 20, 2022
Manufacturer last update
August 02, 2021
Active status
No
Manufacturer
Manufacturer name
NuMED Canada, Inc.
Country
Canada
Country type
NON_EU
Address
45 Second Street West Cornwall
Email
nlaflesh@numedusa.com
Authorized representative
Name
G. van Wageningen B.V.
SRN
NL-AR-000010437
Country
Netherlands
Address
40 Hallenweg Best
Email
a.bos@transequity.nl
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:1998-01-26~2023-07-25, Belgium:1998-01-26~2023-07-25, Bulgaria:1998-01-26~2023-07-25, Croatia:1998-01-26~2023-07-25, Cyprus:1998-01-26~2023-07-25, Czech Republic:1998-01-26~2023-07-25, Denmark:1998-01-26~2023-07-25, Estonia:1998-01-26~2023-07-25, Finland:1998-01-26~2023-07-25, France:1998-01-26~2023-07-25, Germany:1998-01-26~2023-07-25, Greece:1998-01-26~2023-07-25, Hungary:1998-01-26~2023-07-25, Iceland:1998-01-26~2023-07-25, Ireland:1998-01-26~2023-07-25, Italy:1998-01-26~2023-07-25, Latvia:1998-01-26~2023-07-25, Liechtenstein:1998-01-26~2023-07-25, Lithuania:1998-01-26~2023-07-25, Luxembourg:1998-01-26~2023-07-25, Malta:1998-01-26~2023-07-25, Netherlands:1998-01-26~2023-07-25, Norway:1998-01-26~2023-07-25, Poland:1998-01-26~2023-07-25, Portugal:1998-01-26~2023-07-25, Romania:1998-01-26~2023-07-25, Slovakia:1998-01-26~2023-07-25, Slovenia:1998-01-26~2023-07-25, Spain:1998-01-26~2023-07-25, Sweden:1998-01-26~2023-07-25, Turkey:1998-01-26~2023-07-25, United Kingdom (Northern Ireland only):1998-01-26~2023-07-25
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

ARTERIO-VENOUS DEVICES - OTHER

About this record

Access comprehensive regulatory information for Z-5 Atrioseptostomy Catheter 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 10884117002723 and manufactured by NuMED Canada, Inc. in Canada.

This page provides complete registration details including trade name (Z-5 Atrioseptostomy), 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.