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Astrea Click - EUDAMED Registration 00844369008839

Access comprehensive regulatory information for Astrea Click in the European Union medical device market through Pure Global AI's free database. This Class IIb device is registered with EU EUDAMED under Primary DI 00844369008839 and manufactured by Lenstec (Barbados) Inc. in Barbados.

This page provides complete registration details including trade name (Astreaโ„ข Click), manufacturer information, authorized representative details, competent authority (ล tรกtny รบstav pre kontrolu lieฤiv / State Institute for Drug Control ( Slovak CA)), 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 IIb
00844369008839
No
Astrea Click
Trade Name: Astreaโ„ข Click
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Device Description (EMDN)

IOLs, APHAKIC, MULTIFOCAL, ASPHERIC, HYDROPHILIC ACRYLIC

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P030102100202
Trade Name
Astreaโ„ข Click
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00844369008839
Basic UDI
B-00844369008839
Version Date
March 15, 2023
Manufacturer Last Update
January 21, 2022
Active Status
No
Manufacturer
Manufacturer Name
Lenstec (Barbados) Inc.
Country
Barbados
Country Type
NON_EU
Address
Airport Commercial Centre, Pilgrim Road Bridgetown
Email
ihickling@lenstec.com
Authorized Representative
SRN
SK-AR-000007425
Country
Slovakia
Address
Bratislava
Email
officesk@cmi.sk
Telephone
+421 2 5263 1441
Regulatory Information
Competent Authority
ล tรกtny รบstav pre kontrolu lieฤiv / State Institute for Drug Control ( Slovak CA)
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Slovakia
Market Available
Slovakia:2022-05-02~None
Device Characteristics
Human Tissues
No
Animal Tissues
No