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Xen 45 Glaucoma Treatment System
EUDAMEDFDA UDIClass III (EU MDR)
Ref 5507-001Model XEN 45 GTS
Identity
- Trade Name
- XEN 45 GLAUCOMA TREATMENT SYSTEM EUDAMEDXEN Glaucoma Treatment System FDA UDI
- Generic Name
- Glaucoma shunt FDA UDI
- Device Name
- XEN 45 Glaucoma Treatment System EUDAMEDXEN Sterile Injector US FDA UDI
- Model / Reference
- XEN 45 GTS EUDAMED5507-001 EUDAMED5513-001 FDA UDI
- Description
- XEN Sterile Injector US FDA UDI
Identifiers
- Catalog Number
- 5513-001 FDA UDI
- Primary DI / UDI-DI
- 10888628032439 EUDAMEDFDA UDI
- Basic UDI-DI
- B-10888628032439 EUDAMED
- 510(k) Number
- K161457 FDA UDI
- FDA Product Code
- KYF FDA UDI
- EMDN Code
- Q0208 GLAUCOMA DRAINAGES AND KITS EUDAMED
- GMDN Term
- Glaucoma shunt FDA UDI
Classification
- Device Class
- Class III EUDAMEDClass II FDA UDI
- Regulation Number
- 886.3920 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Xen 45 Glaucoma Treatment System by Allergan Sales, LLC — Class III — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-10888628032439 | Class III | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class III | Pending data |
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Manufacturer
- Manufacturer
- Allergan Sales, LLC
- EUDAMED SRN
- US-MF-000001517
- Authorised Representative
- Allergan Pharmaceuticals International Limited IE-AR-000000650
Sources (2)
- EUDAMED 38697433-81ae-4e4a-93bb-18f3fc2c9c77 61 fields · synced Jul 9, 2026
- FDA UDI a4ce3b83-8a89-486b-99ab-7c9a46de40c4 36 fields · synced May 30, 2026