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SunLED Series Surgical Light - EUDAMED Registration 06974724356016

Access comprehensive regulatory information for SunLED Series Surgical Light 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 06974724356016 and manufactured by Mediland Medical Equipment Enterprise Corporation Company in China.

This page provides complete registration details including trade name (SunLED 1), 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
06974724356016
Yes
SunLED Series Surgical Light
Trade Name: SunLED 1
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Device Description (EMDN)

FIXED SCIALYTIC LAMPS

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z12010701
Trade Name
SunLED 1
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06974724356016
Basic UDI
697472435SunLEDHC
Version Date
July 06, 2022
Manufacturer Last Update
October 19, 2021
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
No.29 Qinhuai Rode Nanjing
Email
james_chiang@mediland.com.tw
Authorized Representative
SRN
NL-AR-000002750
Country
Netherlands
Address
130 Weena Zuid Rotterdam
Email
info@luanamed.com
Regulatory Information
Competent Authority
Ministerie van Volksgezondheid, Welzijn en Sport
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Netherlands
Device Characteristics
Human Tissues
No
Animal Tissues
No