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Non-sterile Non-medicated Natural Rubber Latex Male Condoms. - EUDAMED Registration 04260365853123

Access comprehensive regulatory information for Non-sterile Non-medicated Natural Rubber Latex Male Condoms. 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 04260365853123 and manufactured by Innolatex (Thailand) Limited in Thailand.

This page provides complete registration details including trade name (FAIR SQUARED ULTRA THIN), manufacturer information, authorized representative details, competent authority (Malta Medicines Authority), 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
04260365853123
No
Non-sterile Non-medicated Natural Rubber Latex Male Condoms.
Trade Name: FAIR SQUARED ULTRA THIN
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Device Description (EMDN)

CONDOMS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
U110101
Trade Name
FAIR SQUARED ULTRA THIN
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
04260365853123
Basic UDI
B-04260365853123
Active Status
No
Manufacturer
Country
Thailand
Country Type
NON_EU
Address
E 1-6 Export Processing Zone, Southern Industrial Estate, Songkhla
Email
khairunnisa.w@karex.com.my
Authorized Representative
SRN
MT-AR-000000234
Country
Malta
Address
Tower Street Swatar
Email
prrc@advena.mt
Regulatory Information
Competent Authority
Malta Medicines Authority
Applicable Legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed On The Market
Germany
Market Available
Germany:None~2023-05-05
Device Characteristics
Human Tissues
No
Animal Tissues
No