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Ophthalmic Optical Coherence Tomography Systems - EUDAMED Registration 06975994660001

Access comprehensive regulatory information for Ophthalmic Optical Coherence Tomography Systems 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 06975994660001 and manufactured by TowardPi (Shanghai) Medical Technology Ltd. in China.

This page provides complete registration details including trade name (Ophthalmic Optical Coherence Tomography Systems), manufacturer information, authorized representative details, competent authority (DE/CA22 - Bezirksregierung Mรผnster), 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
06975994660001
Yes
Ophthalmic Optical Coherence Tomography Systems
Trade Name: Ophthalmic Optical Coherence Tomography Systems
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Device Description (EMDN)

OPTICAL CONSISTENCY TOMOGRAPHS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z12120121
Trade Name
Ophthalmic Optical Coherence Tomography Systems
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
06975994660001
Basic UDI
697599466YG100KXN
Version Date
July 18, 2024
Manufacturer Last Update
March 06, 2023
Active Status
Yes
Manufacturer
Country
China
Country Type
NON_EU
Address
Room 261, Building 147, No. 500, Zhennan Road, Putuo District Shanghai
Email
RA@towardpi.com
Authorized Representative
SRN
DE-AR-000011194
Country
Germany
Address
10 Borkstrasse Mรผnster
Email
contact@mednet-ecrep.com
Regulatory Information
Competent Authority
DE/CA22 - Bezirksregierung Mรผnster
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Tรผrkiye
Market Available
Tรผrkiye:2024-07-22~2032-07-21
Device Characteristics
Human Tissues
No
Animal Tissues
No