Identity
- Trade Name
- XCalibur EUDAMED
- Device Name
- XCalibur Aneurysm Occlusion Device and Delivery System EUDAMED
- Model / Reference
- 290513-37520 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885015790106 EUDAMED
- Basic UDI-DI
- B-08885015790106 EUDAMED
- EMDN Code
- P0799 VASCULAR AND CARDIAC PROSTHESES - OTHER EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Germany EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
XCalibur by Merlin MD Pte. Ltd. — 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-08885015790106 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Merlin MD Pte. Ltd.
- EUDAMED SRN
- SG-MF-000010547
- Authorised Representative
- MedEnvoy Global BV NL-AR-000024028
Sources (1)
- EUDAMED 43db54b5-2b88-4428-85a5-fd7f1636ce91 61 fields · synced Jun 18, 2026