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Tetraflex HD - EUDAMED Registration 00844369030236

Access comprehensive regulatory information for Tetraflex HD 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 00844369030236 and manufactured by Lenstec (Barbados) Inc. in Barbados.

This page provides complete registration details including trade name (Tetraflexโ„ข HD), 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
00844369030236
No
Tetraflex HD
Trade Name: Tetraflexโ„ข HD
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Device Description (EMDN)

IOLs, APHAKIC, ACCOMMODATIVE, ASPHERIC, HYDROPHILIC ACRYLIC

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P030102110202
Trade Name
Tetraflexโ„ข HD
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00844369030236
Basic UDI
B-00844369030236
Version Date
July 07, 2022
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
Czechia
Market Available
Czechia:2013-07-01~None
Device Characteristics
Human Tissues
No
Animal Tissues
No