← Back to catalogue
XCalibur
EUDAMEDClass III (EU MDR)
Ref 290513-40015Ref 290513-40020Ref 290513-42520Ref 290513-40025Ref 290513-45015Ref 290513-37525Ref 290513-37515Ref 290513-32525Ref 290513-32520Ref 290513-35015Ref 290513-42525
Identity
- Trade Name
- XCalibur EUDAMED
- Device Name
- XCalibur Aneurysm Occlusion Device and Delivery System EUDAMEDXCalibur Aneurysm Occlusion Device and Deliver System EUDAMED
- Model / Reference
- 290513-40015 EUDAMED290513-40020 EUDAMED290513-42520 EUDAMED290513-40025 EUDAMED290513-45015 EUDAMED290513-37525 EUDAMED290513-37515 EUDAMED290513-32525 EUDAMED290513-32520 EUDAMED290513-35015 EUDAMED290513-42525 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08885015790120 EUDAMED08885015790137 EUDAMED08885015790168 EUDAMED08885015790144 EUDAMED08885015790182 EUDAMED08885015790113 EUDAMED08885015790090 EUDAMED08885015790052 EUDAMED08885015790045 EUDAMED08885015790069 EUDAMED08885015790175 EUDAMED
- Basic UDI-DI
- B-08885015790120 EUDAMEDB-08885015790137 EUDAMEDB-08885015790168 EUDAMEDB-08885015790144 EUDAMEDB-08885015790182 EUDAMEDB-08885015790113 EUDAMEDB-08885015790090 EUDAMEDB-08885015790052 EUDAMEDB-08885015790045 EUDAMEDB-08885015790069 EUDAMEDB-08885015790175 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-08885015790120 | 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 (11)
- EUDAMED 67d1b701-c81a-496d-8398-7691caab5638 61 fields · synced Aug 2, 2026
- EUDAMED 9aa987f1-a782-40ba-9627-42f9242f347d 61 fields · synced May 16, 2026
- EUDAMED 920895e5-a814-4438-9b62-89347e29b553 61 fields · synced May 16, 2026
- EUDAMED 3fe8cf88-5673-4ff5-b191-a47a3afe922d 61 fields · synced May 16, 2026
- EUDAMED aca3548e-a8b5-48ea-8638-95d814685024 61 fields · synced May 16, 2026
- EUDAMED 93178023-78b6-4359-b71d-0fad76b07c8e 61 fields · synced May 17, 2026
- EUDAMED 24578f63-2c02-4d8d-b708-19133c4779bb 61 fields · synced May 17, 2026
- EUDAMED 1933e293-fa4b-46c8-9ba6-ce0e936d5dae 61 fields · synced May 17, 2026
- EUDAMED 823aa0ca-f908-4a37-a609-17a97b810097 61 fields · synced May 18, 2026
- EUDAMED 71fc9c7d-3e02-4a38-a1f7-29771bfc8af6 61 fields · synced May 18, 2026
- EUDAMED 06694119-228e-4311-9439-3233cfb7dfe9 61 fields · synced May 19, 2026