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EUDAMED registration 05060548240189No

LINC All Silicone

LINC Medical Systems LtdClass IIbEU EUDAMEDTrade name: LINC All Silicone Catheter
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class IIb
CND nomenclatures code
U010201
Trade name
LINC All Silicone Catheter
Implantable
No
Reusable
No
Measuring function
No
Registration information
Primary DI
05060548240189
Basic UDI
B-05060548240189
Version date
November 23, 2023
Manufacturer last update
September 11, 2023
Active status
No
Manufacturer
Manufacturer name
LINC Medical Systems Ltd
Country
United Kingdom (ex Northern Ireland)
Country type
NON_EU
Address
7 Kingsley Street Leicester LE2 6DY Leicester
Email
sales@linc-medical.co.uk
Authorized representative
Name
MPS Medical Product Service GmbH
SRN
DE-AR-000005009
Country
Germany
Address
20 Borngasse Braunfels
Email
g.froemel@mps-gmbh.eu
Telephone
+49 6442962073
Regulatory information
Competent authority
DE/CA36 - Regierungspräsidium Gießen Abteilung II_Dezernat 25.1 - Arbeitsschutz Gießen I
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Ireland
Market available
Ireland:2023-11-23~2028-12-31
Device characteristics
Human tissues
No
Animal tissues
No
Device description (EMDN)

URETHRAL PROSTATIC AND BLADDER CATHETERS, NELATON, WITH BALLOON

About this record

Access comprehensive regulatory information for LINC All Silicone 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 05060548240189 and manufactured by LINC Medical Systems Ltd in United Kingdom (ex Northern Ireland).

This page provides complete registration details including trade name (LINC All Silicone Catheter), manufacturer information, authorized representative details, competent authority (DE/CA36 - Regierungspräsidium Gießen Abteilung II_Dezernat 25.1 - Arbeitsschutz Gießen I), 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.