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HA-SET060 x10: Sterile, Single Use, Accord Cataract Set - EUDAMED Registration 05404027449265

Access comprehensive regulatory information for HA-SET060 x10: Sterile, Single Use, Accord Cataract Set 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 05404027449265 and manufactured by HASA OPTIX in Belgium.

This page provides complete registration details including trade name (HASA OPTIX), manufacturer information, competent authority (Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten), 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
05404027449265
No
HA-SET060 x10: Sterile, Single Use, Accord Cataract Set
Trade Name: HASA OPTIX
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Device Description (EMDN)

OPHTHALMIC SURGERY INSTRUMENT KITS, SINGLE-USE

Device Classification
Risk Class
Class IIa
CND Nomenclatures Code
Q021113
Trade Name
HASA OPTIX
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
05404027449265
Basic UDI
B-05404027449265
Version Date
February 21, 2025
Manufacturer Last Update
January 16, 2023
Active Status
No
Manufacturer
Manufacturer Name
HASA OPTIX
Country
Belgium
Country Type
EU_MEMBER_STATE
Address
523 Avenue Louise Brussels
Email
info@hasaoptix.com
Regulatory Information
Competent Authority
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Belgium
Market Available
Austria:None~None, Belgium:None~None, Bulgaria:None~None, Croatia:None~None, Cyprus:None~None, Czechia:None~None, Denmark:None~None, Estonia:None~None, Finland:None~None, France:None~None, Germany:None~None, Greece:None~None, Hungary:None~None, Iceland:None~None, Ireland:None~None, Italy:None~None, Latvia:None~None, Liechtenstein:None~None, Lithuania:None~None, Luxembourg:None~None, Malta:None~None, Netherlands:None~None, Norway:None~None, Poland:None~None, Portugal:None~None, Romania:None~None, Slovakia:None~None, Slovenia:None~None, Spain:None~None, Sweden:None~None, Türkiye:None~None, United Kingdom (Northern Ireland only):None~None
Device Characteristics
Human Tissues
No
Animal Tissues
No