Pure Global

Rechargeable Battery Kit - EUDAMED Registration B14004450

Access comprehensive regulatory information for Rechargeable Battery 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 B14004450 and manufactured by BRAEBON Medical Corporation in Canada.

This page provides complete registration details including trade name (Rechargeable Battery Kit), manufacturer information, 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.

Free Database
Powered by Pure Global AI
EUDAMED Official Data
Class I
B14004450
No
Rechargeable Battery Kit
Trade Name: Rechargeable Battery Kit
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

Need help with 30+ markets registration?

Pricing
Device Description (EMDN)

POLYSOMNOGRAPHY INSTRUMENTS - HARDWARE ACCESSORIES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z12100580
Trade Name
Rechargeable Battery Kit
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
B14004450
Basic UDI
++B140BATTERYKITHP
Version Date
March 20, 2024
Manufacturer Last Update
September 28, 2021
Active Status
No
Manufacturer
Country
Canada
Country Type
NON_EU
Address
1-100 Schneider Roaed Kanata
Email
info@braebon.com
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Device Characteristics
Human Tissues
No
Animal Tissues
No