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ABC - EUDAMED Registration 62857410009754

Access comprehensive regulatory information for ABC in the European Union medical device market through Pure Global AI's free database. This Class I device is registered with EU EUDAMED under Primary DI 62857410009754 and manufactured by Dehlawi Optical Industries Co. Ltd. in Saudi Arabia.

This page provides complete registration details including trade name (ABC), manufacturer information, authorized representative details, 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 I
62857410009754
No
ABC
Trade Name: ABC
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Device Description (EMDN)

ORGANIC OPHTHALMIC LENSES - OTHER

Device Classification
Risk Class
Class I
CND Nomenclatures Code
Q0210010199
Trade Name
ABC
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
62857410009754
Basic UDI
6285741ABCEK
Active Status
No
Manufacturer
Country
Saudi Arabia
Country Type
NON_EU
Address
62 Jeddah, 1st Industrial City, Phase 3 100010 Jeddah
Email
deopti@dehlawi.com
Authorized Representative
SRN
BE-AR-000011902
Country
Belgium
Address
Guldenberg 1 Map box 2-4 Antwerpen
Email
eurep@easymedicaldevice.com
Telephone
+32 484 39 01 11
Regulatory Information
Competent Authority
Federaal Agentschap voor Geneesmiddelen en Gezondheidsproducten/ Afdeling Gezondheidsproducten
Applicable Legislation
MDR (REGULATION (EU) 2017/745 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