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Z-Med
EUDAMEDFDA 510(k)Class III (EU MDR)
Ref PDZ367Model 302.1Ref SN025Ref PDZ379Ref SN030Ref PDZ318Ref PDZ314Ref SN028Ref PDZ312Ref SO022Ref SO041Ref SO065Ref SO013Ref PDZ300Ref SO016Ref PDZ369Ref SO077Ref PDZ322Ref PDZ358Ref PDZ381Ref PDZ377Ref PDZ357Ref SN022Ref SO066Ref PDZ325Ref SO005Ref SO027Ref PDZ354Ref PDZ307Ref SN029Ref SO025Ref PDZ347Ref PDZ349Ref SO063Ref PDZ384Ref SO061Ref PDZ319Ref PDZ338Ref PDZ303Ref SN020Ref SO052Ref PDZ363Ref SN024Ref SO054Ref SO073Ref SO048Ref PDZ320Ref SN031Ref PDZ311Ref PDZ337Ref PDZ370Ref SO091Ref SO087Ref PDZ360Ref PDZ344Ref PDZ378Ref PDZ348Ref SN027Ref PDZ395Ref PDZ373Ref PDZ304Ref PDZ301Ref PDZ355Ref PDZ359510(k) K003643Ref PDZ329Ref PDZ397Ref PDZ371Ref PDZ308Ref SO075Ref SO049Ref PDZ330Ref PDZ333Ref PDZ302Ref SO024Ref PDZ327Ref PDZ372Ref SO053Ref SO090
by NuMED, Inc.
Identity
- Trade Name
- Z-MED EUDAMED
- Device Name
- Z-MED EUDAMED
- Model / Reference
- 302.1 EUDAMEDPDZ367 EUDAMEDSN025 EUDAMEDPDZ379 EUDAMEDSN030 EUDAMEDPDZ318 EUDAMEDPDZ314 EUDAMEDSN028 EUDAMEDPDZ312 EUDAMEDSO022 EUDAMEDSO041 EUDAMEDSO065 EUDAMEDSO013 EUDAMEDPDZ300 EUDAMEDSO016 EUDAMEDPDZ369 EUDAMEDSO077 EUDAMEDPDZ322 EUDAMEDPDZ358 EUDAMEDPDZ381 EUDAMEDPDZ377 EUDAMEDPDZ357 EUDAMEDSN022 EUDAMEDSO066 EUDAMEDPDZ325 EUDAMEDSO005 EUDAMEDSO027 EUDAMEDPDZ354 EUDAMEDPDZ307 EUDAMEDSN029 EUDAMEDSO025 EUDAMEDPDZ347 EUDAMEDPDZ349 EUDAMEDSO063 EUDAMEDPDZ384 EUDAMEDSO061 EUDAMEDPDZ319 EUDAMEDPDZ338 EUDAMEDPDZ303 EUDAMEDSN020 EUDAMEDSO052 EUDAMEDPDZ363 EUDAMEDSN024 EUDAMEDSO054 EUDAMEDSO073 EUDAMEDSO048 EUDAMEDPDZ320 EUDAMEDSN031 EUDAMEDPDZ311 EUDAMEDPDZ337 EUDAMEDPDZ370 EUDAMEDSO091 EUDAMEDSO087 EUDAMEDPDZ360 EUDAMEDPDZ344 EUDAMEDPDZ378 EUDAMEDPDZ348 EUDAMEDSN027 EUDAMEDPDZ395 EUDAMEDPDZ373 EUDAMEDPDZ304 EUDAMEDPDZ301 EUDAMEDPDZ355 EUDAMEDPDZ359 EUDAMEDPDZ329 EUDAMEDPDZ397 EUDAMEDPDZ371 EUDAMEDPDZ308 EUDAMEDSO075 EUDAMEDSO049 EUDAMEDPDZ330 EUDAMEDPDZ333 EUDAMEDPDZ302 EUDAMEDSO024 EUDAMEDPDZ327 EUDAMEDPDZ372 EUDAMEDSO053 EUDAMEDSO090 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10887714014939 EUDAMED10887714015455 EUDAMED10887714015134 EUDAMED10887714015554 EUDAMED10887714014090 EUDAMED10887714014014 EUDAMED10887714015516 EUDAMED10887714013970 EUDAMED10887714015677 EUDAMED10887714015776 EUDAMED10887714016193 EUDAMED10887714015639 EUDAMED10887714013734 EUDAMED10887714015653 EUDAMED10887714014977 EUDAMED10887714016339 EUDAMED10887714014151 EUDAMED10887714014755 EUDAMED10887714015172 EUDAMED10887714015097 EUDAMED10887714014731 EUDAMED10887714015394 EUDAMED10887714016216 EUDAMED10887714014212 EUDAMED10887714015592 EUDAMED10887714015752 EUDAMED10887714014670 EUDAMED10887714013871 EUDAMED10887714015530 EUDAMED10887714015714 EUDAMED10887714014595 EUDAMED10887714014632 EUDAMED10887714016155 EUDAMED10887714015233 EUDAMED10887714016117 EUDAMED10887714014113 EUDAMED10887714014472 EUDAMED10887714013796 EUDAMED10887714015356 EUDAMED10887714015936 EUDAMED10887714014854 EUDAMED10887714015431 EUDAMED10887714015974 EUDAMED10887714016254 EUDAMED10887714015851 EUDAMED10887714014137 EUDAMED10887714015578 EUDAMED10887714013956 EUDAMED10887714014458 EUDAMED10887714014991 EUDAMED10887714016575 EUDAMED10887714016490 EUDAMED10887714014793 EUDAMED10887714014557 EUDAMED10887714015110 EUDAMED10887714014618 EUDAMED10887714015493 EUDAMED10887714015318 EUDAMED10887714015059 EUDAMED10887714013819 EUDAMED10887714013758 EUDAMED10887714014694 EUDAMED10887714014779 EUDAMED10887714014298 EUDAMED10887714020398 EUDAMED10887714015011 EUDAMED10887714013895 EUDAMED10887714016292 EUDAMED10887714015875 EUDAMED10887714014311 EUDAMED10887714014373 EUDAMED10887714013772 EUDAMED10887714015691 EUDAMED10887714014250 EUDAMED10887714015035 EUDAMED10887714015950 EUDAMED10887714016551 EUDAMED
- Basic UDI-DI
- B-10887714014939 EUDAMEDB-10887714015455 EUDAMEDB-10887714015134 EUDAMEDB-10887714015554 EUDAMEDB-10887714014090 EUDAMEDB-10887714014014 EUDAMEDB-10887714015516 EUDAMEDB-10887714013970 EUDAMEDB-10887714015677 EUDAMEDB-10887714015776 EUDAMEDB-10887714016193 EUDAMEDB-10887714015639 EUDAMEDB-10887714013734 EUDAMEDB-10887714015653 EUDAMEDB-10887714014977 EUDAMEDB-10887714016339 EUDAMEDB-10887714014151 EUDAMEDB-10887714014755 EUDAMEDB-10887714015172 EUDAMEDB-10887714015097 EUDAMEDB-10887714014731 EUDAMEDB-10887714015394 EUDAMEDB-10887714016216 EUDAMEDB-10887714014212 EUDAMEDB-10887714015592 EUDAMEDB-10887714015752 EUDAMEDB-10887714014670 EUDAMEDB-10887714013871 EUDAMEDB-10887714015530 EUDAMEDB-10887714015714 EUDAMEDB-10887714014595 EUDAMEDB-10887714014632 EUDAMEDB-10887714016155 EUDAMEDB-10887714015233 EUDAMEDB-10887714016117 EUDAMEDB-10887714014113 EUDAMEDB-10887714014472 EUDAMEDB-10887714013796 EUDAMEDB-10887714015356 EUDAMEDB-10887714015936 EUDAMEDB-10887714014854 EUDAMEDB-10887714015431 EUDAMEDB-10887714015974 EUDAMEDB-10887714016254 EUDAMEDB-10887714015851 EUDAMEDB-10887714014137 EUDAMEDB-10887714015578 EUDAMEDB-10887714013956 EUDAMEDB-10887714014458 EUDAMEDB-10887714014991 EUDAMEDB-10887714016575 EUDAMEDB-10887714016490 EUDAMEDB-10887714014793 EUDAMEDB-10887714014557 EUDAMEDB-10887714015110 EUDAMEDB-10887714014618 EUDAMEDB-10887714015493 EUDAMEDB-10887714015318 EUDAMEDB-10887714015059 EUDAMEDB-10887714013819 EUDAMEDB-10887714013758 EUDAMEDB-10887714014694 EUDAMEDB-10887714014779 EUDAMEDB-10887714014298 EUDAMEDB-10887714020398 EUDAMEDB-10887714015011 EUDAMEDB-10887714013895 EUDAMEDB-10887714016292 EUDAMEDB-10887714015875 EUDAMEDB-10887714014311 EUDAMEDB-10887714014373 EUDAMEDB-10887714013772 EUDAMEDB-10887714015691 EUDAMEDB-10887714014250 EUDAMEDB-10887714015035 EUDAMEDB-10887714015950 EUDAMEDB-10887714016551 EUDAMED
- 510(k) Number
- K003643 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 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 | K003643 | Class III | Active |
| EUDAMED | European Union | CE/MDD | B-10887714014939 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- NuMED, Inc.
- EUDAMED SRN
- US-MF-000010948
- Authorised Representative
- EVOMED S.L.U. ES-AR-000047116
Sources (78)
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- EUDAMED 874063b2-c3ab-4ec2-8f15-2762b95debe5 61 fields · synced May 11, 2026
- EUDAMED 9004dc94-e12d-4acc-9c05-1662dc80a208 61 fields · synced May 11, 2026
- EUDAMED 83c6b096-9ad5-4342-a1b3-657f5dbb7f18 61 fields · synced May 16, 2026
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- EUDAMED 592f9afe-171e-4ff7-845c-23522b5e15ff 61 fields · synced May 16, 2026
- EUDAMED baf78dc3-b990-42e9-93ae-7a37f37b6fc6 61 fields · synced May 16, 2026
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- EUDAMED 6187097e-7ce2-4c14-90d7-07ba2f22530c 61 fields · synced May 17, 2026
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- EUDAMED 97e5fb59-0656-44b1-8482-09ed94369a39 61 fields · synced May 18, 2026
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- EUDAMED f4d76ce4-c073-4c2e-9707-e33ee0a26087 61 fields · synced May 18, 2026
- EUDAMED bf868098-8e1b-4f16-9b2b-92aa6ccbb6b8 61 fields · synced May 18, 2026
- EUDAMED 5fcf2777-95f3-4ebd-a09c-55cb97383f8c 61 fields · synced May 18, 2026
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- EUDAMED 4890e641-d1f6-4b65-b1bf-41b268f79926 61 fields · synced May 18, 2026
- EUDAMED 10c14335-84cc-480b-92e8-fd29123eb364 61 fields · synced May 18, 2026
- EUDAMED 2567c96b-39fc-44c6-ab05-2191cb5b603c 61 fields · synced May 18, 2026
- EUDAMED 25140b40-997b-4c93-bb4d-e7425ae0341a 61 fields · synced May 18, 2026
- EUDAMED 0923490b-d9aa-44a6-bf80-fbf852053626 61 fields · synced May 18, 2026
- EUDAMED 828b1ca0-8717-4e27-a64a-542e40b67bb2 61 fields · synced May 18, 2026
- FDA 510(k) K003643 24 fields · synced May 18, 2026
- EUDAMED c3ca1010-2ad1-41c5-94a9-aed9cae5ac80 61 fields · synced Jul 8, 2026
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- EUDAMED 9dcfd8aa-95df-4c76-9c15-f10acd55c8b8 61 fields · synced Jul 10, 2026
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- EUDAMED fb547e13-dd18-45ea-90b3-5bbc8c3139f7 61 fields · synced Jul 12, 2026
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- EUDAMED 602d38c4-1d81-4a49-b49a-c01202f08656 61 fields · synced Jul 20, 2026
- EUDAMED d50dc4b6-c181-41ec-8461-c5bcd0b5319a 61 fields · synced Jul 23, 2026
- EUDAMED 3e11ca54-3167-485d-b67a-a31d1bf0f93c 61 fields · synced Jul 25, 2026
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- EUDAMED 0ebd3dd7-085e-4154-9e4b-fc99799786bc 61 fields · synced Aug 4, 2026