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Universal Light Handle, for use with ‘Gettinge/CASTLE-GRAY2300-2400-2800’ - EUDAMED Registration 05060792972102

Access comprehensive regulatory information for Universal Light Handle, for use with ‘Gettinge/CASTLE-GRAY2300-2400-2800’ 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 05060792972102 and manufactured by Litex Manufacturing, Inc. in United States.

This page provides complete registration details including 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
05060792972102
No
Universal Light Handle, for use with ‘Gettinge/CASTLE-GRAY2300-2400-2800’
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z12010780
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05060792972102
Basic UDI
506079297ULHANDULAU7
Version Date
July 02, 2024
Manufacturer Last Update
May 28, 2021
Active Status
No
Manufacturer
Manufacturer Name
Litex Manufacturing, Inc.
Country
United States
Country Type
NON_EU
Address
1501 Sunshine Drive Glendale
Email
litexmanufacturing@yahoo.com
Authorized Representative
SRN
IE-AR-000002496
Country
Ireland
Address
Block B, The Crescent Building, Dublin 9
Email
EU-Rep@medicaldevicemanagement.com
Telephone
+353 (0) 1893 4143
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
France
Device Characteristics
Human Tissues
No
Animal Tissues
No