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Tyshak NuCLEUS
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref TN034Model 103510(k) K121859
by NuMED, Inc.
Identity
- Trade Name
- Tyshak NuCLEUS EUDAMED
- Device Name
- Tyshak NuCLEUS EUDAMED
- Model / Reference
- 103 EUDAMEDTN034 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10887714020732 EUDAMED
- Basic UDI-DI
- B-10887714020732 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 — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121859 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-10887714020732 | 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 (2)
- EUDAMED 22158ad8-d492-4b78-a65e-c6f6d46982df 85 fields · synced Jun 18, 2026
- FDA 510(k) K121859 1 fields · synced May 18, 2026