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Digital Refractor - EUDAMED Registration 08800019600916

Access comprehensive regulatory information for Digital Refractor 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 08800019600916 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 I
08800019600916
Yes
Digital Refractor
Trade Name: HUVITZ
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Device Description (EMDN)

OPTOMETERS

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Z12120115
Trade Name
HUVITZ
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08800019600916
Basic UDI
88000196DR001C8
Version Date
July 04, 2023
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
France
Device Characteristics
Human Tissues
No
Animal Tissues
No