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EUDAMED registration D-URONOR2SS1230SVTHNo

Sterile Urethral Latex Foley Balloon Catheters

Uro Technology Sdn. Bhd.Class IIbEU EUDAMEDTrade name: Norta
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIb
CND nomenclatures code
U010199
Trade name
Norta
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
D-URONOR2SS1230SVTH
Basic UDI
B-URONOR2SS1230SVTH
Version date
March 07, 2025
Manufacturer last update
February 19, 2024
Active status
No
Manufacturer
Manufacturer name
Uro Technology Sdn. Bhd.
Country
Malaysia
Country type
NON_EU
Address
Lot 2491. Batu 39 ½, Pontian Besar Pontian
Email
khairunnisa.w@karex.com.my
Authorized representative
Name
Advena Limited
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~None
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

URETHRAL PROSTATIC AND BLADDER CATHETERS, NOT SELF-RETAINED - OTHER

About this record

Access comprehensive regulatory information for Sterile Urethral Latex Foley Balloon Catheters 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 D-URONOR2SS1230SVTH and manufactured by Uro Technology Sdn. Bhd. in Malaysia.

This page provides complete registration details including trade name (Norta), 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.