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Light source - EUDAMED Registration 06973031299368

Access comprehensive regulatory information for Light source in the European Union medical device market through Pure Global AI's free database. This Class IIa device is registered with EU EUDAMED under Primary DI 06973031299368 and manufactured by Guangdong Optomedic Technologies, Inc. in China.

This page provides complete registration details including trade name (Stellar Light Source), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24), 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 IIa
06973031299368
Yes
Light source
Trade Name: Stellar Light Source
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Device Description (EMDN)

LIGHT SOURCES FOR ENDOSCOPY AND MINIMALLY INVASIVE SURGERY

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z12020402
Trade Name
Stellar Light Source
Implantable
No
Reusable
Yes
Measuring Function
No
Registration Information
Primary DI
06973031299368
Basic UDI
697303129GY20C01BY
Version Date
December 19, 2024
Manufacturer Last Update
September 16, 2021
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
2 Yonganbei Street Foshan
Email
liaokaiyi@optomedic.com
Authorized Representative
SRN
DE-AR-000005132
Country
Germany
Address
12 Am Schulzentrum Kaarst
Email
eu-rep@share-info.com
Telephone
+49 01795666508
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Germany:None~None, Ireland:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No