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Asqelio Toric Preloaded IOL Delivery System - EUDAMED Registration 00840149813617

Access comprehensive regulatory information for Asqelio Toric Preloaded IOL Delivery System 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 00840149813617 and manufactured by AST VisionCare Inc. in United States.

This page provides complete registration details including 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 IIb
00840149813617
No
Asqelio Toric Preloaded IOL Delivery System
EU EUDAMED Registered Medical Device
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Device Description (EMDN)

IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P030102090301
Implantable
Yes
Reusable
No
Measuring Function
No
Registration Information
Primary DI
00840149813617
Basic UDI
B-00840149813617
Active Status
No
Manufacturer
Manufacturer Name
AST VisionCare Inc.
Country
United States
Country Type
NON_EU
Address
9 Linnell Circle Billerica
Email
ra@astp.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
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Spain
Market Available
Austria:None~None, Belgium:None~None, France:None~None, Germany:None~None, Italy:None~None, Netherlands:None~None, Poland:None~None, Portugal:None~None, Spain:None~None, Tรผrkiye:None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No