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Xen 63 Glaucoma Treatment System
EUDAMEDClass III (EU MDR)
Ref 5501-001Model XEN 63 GTS
Identity
- Trade Name
- XEN 63 GLAUCOMA TREATMENT SYSTEM EUDAMED
- Device Name
- XEN 63 Glaucoma Treatment System EUDAMED
- Model / Reference
- XEN 63 GTS EUDAMED5501-001 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05016007207583 EUDAMED
- Basic UDI-DI
- B-05016007207583 EUDAMED
- EMDN Code
- Q0208 GLAUCOMA DRAINAGES AND KITS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Ireland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
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
Xen 63 Glaucoma Treatment System by Allergan Sales, LLC — Class III — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-05016007207583 | Class III | Active |
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Manufacturer
- Manufacturer
- Allergan Sales, LLC
- EUDAMED SRN
- US-MF-000001517
- Authorised Representative
- Allergan Pharmaceuticals International Limited IE-AR-000000650
Sources (1)
- EUDAMED abfa2b02-a5b8-476b-a034-9226be395ec2 61 fields · synced Jul 24, 2026