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EUDAMED registration 06973031299436Yes

Image Processing Unit

Guangdong Optomedic Technologies, Inc.Class IEU EUDAMEDTrade name: Stellar Image Processing Unit
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Z12020499
Trade name
Stellar Image Processing Unit
Implantable
No
Reusable
Yes
Measuring function
No
Registration information
Primary DI
06973031299436
Basic UDI
697303129GK20E016L
Version date
September 26, 2024
Manufacturer last update
September 16, 2021
Active status
Yes
Manufacturer
Manufacturer name
Guangdong Optomedic Technologies, Inc.
Country
China
Country type
NON_EU
Address
2 Yonganbei Street Foshan
Email
liaokaiyi@optomedic.com
Authorized representative
Name
Share info GmbH
SRN
DE-AR-000005132
Country
Germany
Address
83 Heerdter Lohweg Düsseldorf
Email
eu-rep@share-info.com
Regulatory information
Competent authority
DE/CA20, Bezirksregierung Düsseldorf Dezernat 24
Applicable legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed on the market
Ireland
Market available
Ireland:None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

INSTRUMENTS FOR THE ACQUISITION AND MANAGEMENT OF ENDOSCOPIC AND MINIMALLY INVASIVE SURGERY IMAGES – OTHER

About this record

Access comprehensive regulatory information for Image Processing Unit 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 06973031299436 and manufactured by Guangdong Optomedic Technologies, Inc. in China.

This page provides complete registration details including trade name (Stellar Image Processing Unit), manufacturer information, authorized representative details, competent authority (DE/CA20, Bezirksregierung Düsseldorf 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.