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NuCLEUS-X
EUDAMEDClass III (EU MDR)
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by NuMED, Inc.
Identity
- Trade Name
- NuCLEUS-X EUDAMEDNuCLEUS EUDAMED
- Device Name
- NuCLEUS-X EUDAMEDNuCLEUS EUDAMED
- Model / Reference
- 230X EUDAMEDPVN410 EUDAMEDPVN411 EUDAMEDPVN417 EUDAMEDPVN409 EUDAMED230 EUDAMEDPVN230 EUDAMEDPVN403 EUDAMEDPVN401 EUDAMEDPVN413 EUDAMEDPVN416 EUDAMEDPVN242 EUDAMEDPVN404 EUDAMEDPVN243 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10887714009492 EUDAMED10887714009508 EUDAMED10887714009560 EUDAMED10887714009485 EUDAMED10887714032995 EUDAMED10887714009423 EUDAMED10887714009409 EUDAMED10887714009522 EUDAMED10887714009553 EUDAMED10887714033114 EUDAMED10887714009430 EUDAMED10887714033121 EUDAMED
- Basic UDI-DI
- B-10887714009492 EUDAMEDB-10887714009508 EUDAMEDB-10887714009560 EUDAMEDB-10887714009485 EUDAMEDB-10887714032995 EUDAMEDB-10887714009423 EUDAMEDB-10887714009409 EUDAMEDB-10887714009522 EUDAMEDB-10887714009553 EUDAMEDB-10887714033114 EUDAMEDB-10887714009430 EUDAMEDB-10887714033121 EUDAMED
- EMDN Code
- C019014 CARDIAC VALVULOPLASTY CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMED
- Market of Registration
- Belgium EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
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
NuCLEUS-X by NuMED, Inc. — 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-10887714009492 | Class III | Active |
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Manufacturer
- Manufacturer
- NuMED, Inc.
- EUDAMED SRN
- US-MF-000010948
- Authorised Representative
- G. van Wageningen B.V. NL-AR-000010437
Sources (12)
- EUDAMED 3c46e815-7478-4a34-8b4a-61ada7f71124 61 fields · synced Aug 2, 2026
- EUDAMED d2a8da8b-49c7-4252-bbb4-ae776dfeaa09 61 fields · synced May 17, 2026
- EUDAMED dd7a73dc-e7ce-444b-9dc5-0cf4e8ee78e8 61 fields · synced May 17, 2026
- EUDAMED 21364dff-2414-48b0-af88-8e2dcb91d79e 61 fields · synced May 17, 2026
- EUDAMED a6ee6736-8cfe-4b05-bb46-f6068b9c0ff4 61 fields · synced May 17, 2026
- EUDAMED 6be6035f-6a90-4d17-ab49-61487f582861 61 fields · synced May 18, 2026
- EUDAMED 3201b4b1-158b-4d78-a5db-1c990b038d30 61 fields · synced May 18, 2026
- EUDAMED 9d3cf9b1-6a83-4e31-a351-966744801673 61 fields · synced May 18, 2026
- EUDAMED 33bd97e9-8954-40fe-b0b0-af747eee959e 61 fields · synced May 18, 2026
- EUDAMED dcf53f4c-f6b7-4abf-acc1-24398a1228d0 61 fields · synced Jul 8, 2026
- EUDAMED 1dfbd81a-c575-4647-800f-f3d7b0078603 61 fields · synced Jul 11, 2026
- EUDAMED be9e625f-3b42-4df1-8b8b-2dd3af4167e2 61 fields · synced Aug 1, 2026