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Non-sterile, Non-medicated Synthetic Nitrile Male Condoms - EUDAMED Registration 09300711095083

Access comprehensive regulatory information for Non-sterile, Non-medicated Synthetic Nitrile 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 09300711095083 and manufactured by Innolatex (Thailand) Limited in Thailand.

This page provides complete registration details including trade name (Durex Intense), 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
09300711095083
No
Non-sterile, Non-medicated Synthetic Nitrile Male Condoms
Trade Name: Durex Intense
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Device Description (EMDN)

CONDOMS

Device Classification
Risk Class
Class IIb
CND Nomenclatures Code
U110101
Trade Name
Durex Intense
Implantable
No
Reusable
No
Measuring Function
No
Registration Information
Primary DI
09300711095083
Basic UDI
88586938-NMSNCM-FX
Version Date
January 20, 2025
Manufacturer Last Update
January 23, 2024
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
MDR (REGULATION (EU) 2017/745 on medical devices)
Device Characteristics
Human Tissues
No
Animal Tissues
No