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MINI WELL TORIC (KIT) and MINI WELL PROXA TORIC (KIT) - EUDAMED Registration 08027864088465

Access comprehensive regulatory information for MINI WELL TORIC (KIT) and MINI WELL PROXA TORIC (KIT) 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 08027864088465 and manufactured by SIFI S.p.A. in Italy.

This page provides complete registration details including trade name (KIT MINI WELL TORIC +19.5SE CL1.5), manufacturer information, competent authority (Ministero della salute - Direzione generale dei dispositivi medici e del servizio farmaceutico), 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
08027864088465
No
MINI WELL TORIC (KIT) and MINI WELL PROXA TORIC (KIT)
Trade Name: KIT MINI WELL TORIC +19.5SE CL1.5
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Device Description (EMDN)

IOLs, APHAKIC, MULTIFOCAL, TORIC, HYDROPHILIC ACRYLIC

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
P030102100302
Trade Name
KIT MINI WELL TORIC +19.5SE CL1.5
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
08027864088465
Basic UDI
8027864SIFIMDF35NE
Version Date
March 05, 2025
Manufacturer Last Update
March 11, 2022
Active Status
No
Manufacturer
Manufacturer Name
SIFI S.p.A.
Country
Italy
Country Type
EU_MEMBER_STATE
Address
36 Via Ercole Patti 95025 Aci Sant'antonio Catania
Email
info@sifigroup.com
Regulatory Information
Competent Authority
Ministero della salute - Direzione generale dei dispositivi medici e del servizio farmaceutico
Applicable Legislation
MDR (REGULATION (EU) 2017/745 on medical devices)
Device Characteristics
Human Tissues
No
Animal Tissues
No