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3D Reconstruction Workstation - EUDAMED Registration 06973031299306

Access comprehensive regulatory information for 3D Reconstruction 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 06973031299306 and manufactured by Guangdong Optomedic Technologies, Inc. in China.

This page provides complete registration details including trade name (3D Reconstruction Workstation), 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 I
06973031299306
Yes
3D Reconstruction Workstation
Trade Name: 3D Reconstruction Workstation
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Device Description (EMDN)

VARIOUS INSTRUMENTS FOR GENERAL AND MULTIDISCIPLINARY SURGERY - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z12019099
Trade Name
3D Reconstruction Workstation
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
06973031299306
Basic UDI
697303129FM020155
Version Date
September 27, 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
83 Heerdter Lohweg Dรผsseldorf
Email
eu-rep@share-info.com
Regulatory Information
Competent Authority
DE/CA20, Bezirksregierung Dรผsseldorf Dezernat 24
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Ireland
Market Available
Ireland:2024-09-25~None
Device Characteristics
Human Tissues
No
Animal Tissues
No