EUDAMED registration 05060792972102NoUniversal Light Handle, for use with ‘Gettinge/CASTLE-GRAY2300-2400-2800’
- Risk class
- Class I
- CND nomenclatures code
- Z12010780
- Implantable
- No
- Reusable
- No
- Measuring function
- No
- Primary DI
- 05060792972102
- Basic UDI
- 506079297ULHANDULAU7
- Version date
- July 02, 2024
- Manufacturer last update
- May 28, 2021
- Active status
- No
- Manufacturer name
- Litex Manufacturing, Inc.
- Country
- United States
- Country type
- NON_EU
- Address
- 1501 Sunshine Drive Glendale
- litexmanufacturing@yahoo.com
- SRN
- IE-AR-000002496
- Country
- Ireland
- Address
- Block B, The Crescent Building, Dublin 9
- EU-Rep@medicaldevicemanagement.com
- Telephone
- +353 (0) 1893 4143
- Competent authority
- Health Products Regulatory Authority, Medical Devices Department
- Applicable legislation
- MDR (REGULATION (EU) 2017/745 on medical devices)
- Placed on the market
- France
- Human tissues
- No
- Animal tissues
- No
SCIALYTIC LAMP LIGHTING SYSTEMS - HARDWARE ACCESSORIES
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.