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Cervical Cytology Image Processing Software - EUDAMED Registration 06976543600011

Access comprehensive regulatory information for Cervical Cytology Image Processing Software in the European Union medical device market through Pure Global AI's free database. This Class A device is registered with EU EUDAMED under Primary DI 06976543600011 and manufactured by Hangzhou PathoAl Technology Co., Ltd. in China.

This page provides complete registration details including manufacturer information, authorized representative details, competent authority (DE/CA29 - Regierungsprรคsidium Darmstadt Abteilung Arbeitsschutz und Umwelt), 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 A
06976543600011
No
Cervical Cytology Image Processing Software
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

VARIOUS PROCESSING INSTRUMENTS FOR HYSTOLOGY / CYTOLOGY - IVD MEDICAL DEVICE SOFTWARE

Device Classification
Risk Class
Class A
CND Nomenclatures Code
W0202059092
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06976543600011
Basic UDI
697654360Patholnsight-TVC
Version Date
July 06, 2023
Manufacturer Last Update
June 27, 2023
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No. 258 Xiqin Street, Yuhang District 7F, Building 2 Hangzhou, Zhejiang Province
Email
wufang@pathoai.com
Authorized Representative
SRN
DE-AR-000016611
Country
Germany
Address
13 Schokoladenring Hattersheim am Main
Email
ARcontact@biodomieurope.de
Regulatory Information
Competent Authority
DE/CA29 - Regierungsprรคsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
Applicable Legislation
IVDR (REGULATION (EU) 2017/746 on in vitro diagnostic medical devices)
Placed On The Market
Germany
Device Characteristics
Human Tissues
No
Animal Tissues
No