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Zephyr Hoverboards & Accessories - EUDAMED Registration B237ZXLATB140

Access comprehensive regulatory information for Zephyr Hoverboards & Accessories 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 B237ZXLATB140 and manufactured by Diacor Inc. in United States.

This page provides complete registration details including trade name (Zephyr Patient Positioning and Transfer System), manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), 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
B237ZXLATB140
No
Zephyr Hoverboards & Accessories
Trade Name: Zephyr Patient Positioning and Transfer System
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Device Description (EMDN)

PATIENT TRANSFER BOARDS AND TABLES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
V080504
Trade Name
Zephyr Patient Positioning and Transfer System
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
B237ZXLATB140
Basic UDI
++B237HOVERBOARDV7
Version Date
January 23, 2025
Manufacturer Last Update
August 20, 2024
Active Status
No
Manufacturer
Manufacturer Name
Diacor Inc.
Country
United States
Country Type
NON_EU
Address
1236 South Airstrip Lane Mount Pleasant
Email
tami@diacorinc.com
Authorized Representative
SRN
IE-AR-000003995
Country
Ireland
Address
5 Fitzwilliam Square East Dublin D2
Email
info@ecrep.ie
Telephone
+353 89 225 1951
Regulatory Information
Competent Authority
Health Products Regulatory Authority, Medical Devices Department
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
No