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Tyshak NuCLEUS
EUDAMEDClass III (EU MDR)
Ref TN016Model 103Ref TN028Ref TN037Ref TN011Ref TN007Ref TN024Ref TN005Ref TN030Ref TN023Ref TN031Ref TN002Ref TN029Ref TN026Ref TN032Ref TN017Ref TN003Ref TN033Ref TN018Ref TN004Ref TN036Ref TN013
by NuMED, Inc.
Identity
- Trade Name
- Tyshak NuCLEUS EUDAMED
- Device Name
- Tyshak NuCLEUS EUDAMED
- Model / Reference
- 103 EUDAMEDTN016 EUDAMEDTN028 EUDAMEDTN037 EUDAMEDTN011 EUDAMEDTN007 EUDAMEDTN024 EUDAMEDTN005 EUDAMEDTN030 EUDAMEDTN023 EUDAMEDTN031 EUDAMEDTN002 EUDAMEDTN029 EUDAMEDTN026 EUDAMEDTN032 EUDAMEDTN017 EUDAMEDTN003 EUDAMEDTN033 EUDAMEDTN018 EUDAMEDTN004 EUDAMEDTN036 EUDAMEDTN013 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10887714020558 EUDAMED10887714020671 EUDAMED10887714020763 EUDAMED10887714020503 EUDAMED10887714020466 EUDAMED10887714020633 EUDAMED10887714020442 EUDAMED10887714020695 EUDAMED10887714020626 EUDAMED10887714020701 EUDAMED10887714020411 EUDAMED10887714020688 EUDAMED10887714020657 EUDAMED10887714020718 EUDAMED10887714020565 EUDAMED10887714020428 EUDAMED10887714020725 EUDAMED10887714020572 EUDAMED10887714020435 EUDAMED10887714020756 EUDAMED10887714020527 EUDAMED
- Basic UDI-DI
- B-10887714020558 EUDAMEDB-10887714020671 EUDAMEDB-10887714020763 EUDAMEDB-10887714020503 EUDAMEDB-10887714020466 EUDAMEDB-10887714020633 EUDAMEDB-10887714020442 EUDAMEDB-10887714020695 EUDAMEDB-10887714020626 EUDAMEDB-10887714020701 EUDAMEDB-10887714020411 EUDAMEDB-10887714020688 EUDAMEDB-10887714020657 EUDAMEDB-10887714020718 EUDAMEDB-10887714020565 EUDAMEDB-10887714020428 EUDAMEDB-10887714020725 EUDAMEDB-10887714020572 EUDAMEDB-10887714020435 EUDAMEDB-10887714020756 EUDAMEDB-10887714020527 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
Tyshak NuCLEUS 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-10887714020558 | Class III | Active |
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Manufacturer
- Manufacturer
- NuMED, Inc.
- EUDAMED SRN
- US-MF-000010948
- Authorised Representative
- EVOMED S.L.U. ES-AR-000047116
Sources (21)
- EUDAMED 4d205aee-8f2e-4f0a-9cb2-a154dea1d48f 61 fields · synced Aug 2, 2026
- EUDAMED fc831426-529d-491e-9df2-e602d93240c9 61 fields · synced May 16, 2026
- EUDAMED e37fe280-f64f-43fd-9c45-bf73f26c02d7 61 fields · synced May 16, 2026
- EUDAMED b891d139-1694-46a8-aa2e-87dd2591b2fd 61 fields · synced May 16, 2026
- EUDAMED e65db8a2-7ccc-46c9-bb38-64eecde8b978 61 fields · synced May 16, 2026
- EUDAMED be09c748-6083-43fe-b6b5-f79d0a09c26a 61 fields · synced May 16, 2026
- EUDAMED f891f625-1ee1-4d48-871d-bb71828dfc2f 61 fields · synced May 17, 2026
- EUDAMED fc3a58e4-d65a-4e22-af00-90e2e97161ee 61 fields · synced May 17, 2026
- EUDAMED a396c2b0-2dbe-4957-b39d-39a2dd8766e1 61 fields · synced May 17, 2026
- EUDAMED c4698cac-eec0-4b37-a6cf-d476b99c73b8 61 fields · synced May 17, 2026
- EUDAMED 1d3804c2-8411-45cb-9c05-43025d10b9fe 61 fields · synced May 17, 2026
- EUDAMED dac11421-ddd8-469c-85ef-b66a68e381a8 61 fields · synced May 18, 2026
- EUDAMED 88ebd8f4-e6da-4bde-9299-bed5fe6e7901 61 fields · synced May 18, 2026
- EUDAMED 8502ecbc-bce9-409d-90a9-e5ccf86c6023 61 fields · synced May 18, 2026
- EUDAMED f8f9cd1d-3b80-439e-8842-6d37b76215f8 61 fields · synced May 18, 2026
- EUDAMED 2653422d-f0be-4d5f-9e55-382de02eb133 61 fields · synced May 18, 2026
- EUDAMED 6e51cc7b-c976-4aae-8c37-7a281dbed667 61 fields · synced May 18, 2026
- EUDAMED 3261de05-28b8-48c8-944f-c09e4e8b6954 61 fields · synced May 18, 2026
- EUDAMED 89906900-680e-4a49-9e14-70c07d03e9bd 61 fields · synced May 18, 2026
- EUDAMED fad96144-c334-4db6-88e3-d94595b69ace 61 fields · synced May 18, 2026
- EUDAMED 0468de33-286f-4724-a176-b7a0a75b7dff 61 fields · synced May 19, 2026