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Corneal Topographer - EUDAMED Registration 08800019600770

Access comprehensive regulatory information for Corneal Topographer 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 08800019600770 and manufactured by Huvitz Co., Ltd. in Republic of Korea.

This page provides complete registration details including trade name (HUVITZ), manufacturer information, authorized representative details, competent authority (DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover), 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
08800019600770
Yes
Corneal Topographer
Trade Name: HUVITZ
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Device Description (EMDN)

COMPUTERISED CORNEAL TOPOGRAPHS

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Z12120123
Trade Name
HUVITZ
Implantable
No
Reusable
No
Measuring Function
Yes
Registration Information
Primary DI
08800019600770
Basic UDI
88000196TG001FB
Version Date
September 19, 2024
Manufacturer Last Update
November 03, 2021
Active Status
Yes
Manufacturer
Manufacturer Name
Huvitz Co., Ltd.
Country
Republic of Korea
Country Type
NON_EU
Address
38, 170beon-gil, Burim-ro, Dongan-gu Anyang-si, Gyeonggi-do,
Email
heohm@huvitz.com
Authorized Representative
SRN
DE-AR-000005430
Country
Germany
Address
41 Schiffgraben Hannover
Email
info@mdssar.com
Regulatory Information
Competent Authority
DE/CA09 - Staatliches Gewerbeaufsichtsamt Hannover
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Placed On The Market
Germany
Market Available
Germany:2024-09-12~2029-09-11
Device Characteristics
Human Tissues
No
Animal Tissues
No