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Z-Med Ii
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref PDZ611Model 305.1Ref SN003Model 105Ref SO046Model 302.1Ref PDZ610510(k) K030589
by NuMED, Inc.
Identity
- Trade Name
- Z-MED II EUDAMEDTyshak II EUDAMEDZ-MED EUDAMED
- Device Name
- Z-MED II EUDAMEDTyshak II EUDAMEDZ-MED EUDAMED
- Model / Reference
- 305.1 EUDAMEDPDZ611 EUDAMED105 EUDAMEDSN003 EUDAMED302.1 EUDAMEDSO046 EUDAMEDPDZ610 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10887714019040 EUDAMED10887714013024 EUDAMED10887714015813 EUDAMED10887714019002 EUDAMED
- Basic UDI-DI
- B-10887714019040 EUDAMEDB-10887714013024 EUDAMEDB-10887714015813 EUDAMEDB-10887714019002 EUDAMED
- 510(k) Number
- K030589 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
- EMDN Code
- C019014 CARDIAC VALVULOPLASTY CATHETERS EUDAMED
Classification
- Device Class
- Class III EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Market of Registration
- Belgium EUDAMED
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
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
Z-Med Ii 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 | K030589 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-10887714019040 | 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 (5)
- EUDAMED c5c98747-f7ec-48ec-a183-2d19a0c50319 61 fields · synced Sep 18, 2026
- EUDAMED 91f06d28-c867-455a-98de-9f25c4394ce9 61 fields · synced May 17, 2026
- EUDAMED 5978160a-7943-4194-9a3a-93dbca68f301 61 fields · synced May 17, 2026
- EUDAMED 078578e0-766c-4ce1-8b89-07aba536c900 61 fields · synced May 17, 2026
- FDA 510(k) K030589 24 fields · synced May 18, 2026