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EUDAMED registration 06973031299276Yes

Fluorescence Image Analysis Workstation

Guangdong Optomedic Technologies, Inc.Class IEU EUDAMEDTrade name: Fluorescence Image Analysis Workstation
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class I
CND nomenclatures code
Z12019099
Trade name
Fluorescence Image Analysis Workstation
Implantable
No
Reusable
No
Measuring function
Yes
Registration information
Primary DI
06973031299276
Basic UDI
697303129FM01014Y
Version date
December 03, 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
12 Am Schulzentrum Kaarst
Email
eu-rep@share-info.com
Telephone
+49 01795666508
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
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER

About this record

Access comprehensive regulatory information for Fluorescence Image Analysis Workstation 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 06973031299276 and manufactured by Guangdong Optomedic Technologies, Inc. in China.

This page provides complete registration details including trade name (Fluorescence Image Analysis Workstation), 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.