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Leadwire Kit - EUDAMED Registration B1408620601

Access comprehensive regulatory information for Leadwire Kit 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 B1408620601 and manufactured by BRAEBON Medical Corporation in Canada.

This page provides complete registration details including trade name (Leadwire Kit), 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 I
B1408620601
Yes
Leadwire Kit
Trade Name: Leadwire Kit
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Device Description (EMDN)

POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z12100580
Trade Name
Leadwire Kit
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
B1408620601
Basic UDI
++B140LabLeadsT2
Version Date
August 28, 2024
Manufacturer Last Update
March 17, 2021
Active Status
Yes
Manufacturer
Country
Canada
Country Type
NON_EU
Address
100 Schneider Road Kanata
Email
info@braebon.com
Authorized Representative
SRN
NL-AR-000000111
Country
Netherlands
Address
13 Esdoornlaan Maarn
Email
office@cepartner4u.com
Telephone
+31343442524
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
France:None~None, Germany:None~None, Italy:None~None, Spain:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No