Identity
- Trade Name
- Tyshak II EUDAMED
- Device Name
- Tyshak II EUDAMED
- Model / Reference
- 105 EUDAMEDSO021 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10887714013093 EUDAMED
- Basic UDI-DI
- B-10887714013093 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 II 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-10887714013093 | 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 (1)
- EUDAMED 5e4a5974-8864-407a-a2b0-9a0bcad3714a 61 fields · synced May 23, 2026