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Soft Contact Lens - EUDAMED Registration 06921054600012

Access comprehensive regulatory information for Soft Contact Lens 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 06921054600012 and manufactured by Gansu Constar Technology Group Co., Ltd. in China.

This page provides complete registration details including trade name (Freshlady), manufacturer information, authorized representative details, competent authority (DE/CA29 - Regierungspräsidium 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 IIa
06921054600012
No
Soft Contact Lens
Trade Name: Freshlady
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Device Description (EMDN)

CONTACT LENSES - HYDROGEL, REUSABLE

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Q0210040102
Trade Name
Freshlady
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
06921054600012
Basic UDI
B-06921054600012
Version Date
April 24, 2024
Manufacturer Last Update
April 22, 2024
Active Status
No
Manufacturer
Country
China
Country Type
NON_EU
Address
No.10, Chuangxin South Road, Baiyin District Baiyin, Gansu P.R.
Email
ksdjt@foxmail.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 - Regierungspräsidium Darmstadt Abteilung Arbeitsschutz und Umwelt
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Device Characteristics
Human Tissues
No
Animal Tissues
No