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EUDAMED registration 10888628032439No

XEN 45 Glaucoma Treatment System

Allergan Sales, LLCClass IIIEU EUDAMEDTrade name: XEN 45 GLAUCOMA TREATMENT SYSTEM
VerifiedEUDAMED · official EU database
Device classification
Risk class
Class III
CND nomenclatures code
Q0208
Trade name
XEN 45 GLAUCOMA TREATMENT SYSTEM
Implantable
Yes
Reusable
No
Measuring function
No
Registration information
Primary DI
10888628032439
Basic UDI
B-10888628032439
Version date
March 06, 2025
Manufacturer last update
November 21, 2024
Active status
No
Manufacturer
Manufacturer name
Allergan Sales, LLC
Country
United States
Country type
NON_EU
Address
2525 Dupont Drive Irvine, California
Email
customerservice@abbvie.com
Authorized representative
Name
Allergan Pharmaceuticals International Limited
SRN
IE-AR-000000650
Country
Ireland
Address
Clonshaugh Business & Technology Park Dublin 17
Email
EU_AR@abbvie.com
Telephone
+353 1 435 7700
Regulatory information
Competent authority
Health Products Regulatory Authority, Medical Devices Department
Applicable legislation
MDD (Directive 93/42/EEC on Medical Devices)
Placed on the market
Ireland
Market available
Italy:2013-08-06~None, Liechtenstein:2013-08-06~None, Lithuania:2013-08-06~None, Luxembourg:2013-08-06~None, Latvia:2013-08-06~None, Malta:2013-08-06~None, Netherlands:2013-08-06~None, Norway:2013-08-06~None, Poland:2013-08-06~None, Portugal:2013-08-06~None, Romania:2013-08-06~None, Sweden:2013-08-06~None, Slovenia:2013-08-06~None, Slovakia:2013-08-06~None, Türkiye:2013-08-06~None, United Kingdom (Northern Ireland only):2013-08-06~None, Iceland:2013-08-06~None, Ireland:2013-08-06~None, Hungary:2013-08-06~None, Croatia:2013-08-06~None, Greece:2013-08-06~None, France:2013-08-06~None, Finland:2013-08-06~None, Spain:2013-08-06~None, Estonia:2013-08-06~None, Denmark:2013-08-06~None, Germany:2013-08-06~None, Czechia:2013-08-06~None, Cyprus:2013-08-06~None, Bulgaria:2013-08-06~None, Belgium:2013-08-06~None, Austria:2013-08-06~None
Device characteristics
Human tissues
No
Animal tissues
Yes
Device description (EMDN)

GLAUCOMA DRAINAGES AND KITS

About this record

Access comprehensive regulatory information for XEN 45 Glaucoma Treatment System in the European Union medical device market through Pure Global AI's free database. This Class III device is registered with EU EUDAMED under Primary DI 10888628032439 and manufactured by Allergan Sales, LLC in United States.

This page provides complete registration details including trade name (XEN 45 GLAUCOMA TREATMENT SYSTEM), manufacturer information, authorized representative details, competent authority (Health Products Regulatory Authority, Medical Devices Department), 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.