Pure Global
00840149813389

Asqelio™ Toric Soft Hydrophobic Intraocular Lens

AST VisionCare Inc.·Class IIb·EU EUDAMEDNo
Device classification
Risk class
Class IIb
CND nomenclatures code
P030102090301
Implantable
Yes
Reusable
No
Measuring function
No
Registration information
Primary DI
00840149813389
Basic UDI
B-00840149813389
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
Name
MDSS GmbH
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, Türkiye:None~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC

About this record

Access comprehensive regulatory information for Asqelio™ Toric Soft Hydrophobic Intraocular Lens 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 00840149813389 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.