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Z-Med Ii

EUDAMEDFDA 510(k)

Class III (EU MDR)

Ref PDZ662Model 305.1Ref SO019Model 105Ref PDC513Ref PDZ638Ref PDZ667Ref SN044Ref SO029Ref PDC543Ref PDZ600Ref PDZ613Ref SN033Ref PDZ676Ref PDZ617Ref SO042Ref PDC514Ref PDZ625Ref PDZ624Ref PDZ666Ref PDZ635Ref SN034Ref SO004Ref SN010Ref PDC526Ref SO045Ref PDC505Ref PDC529Ref SO001Ref SN048Ref PDC548Ref SO002Ref PDC522Ref PDZ607Ref PDC509Ref SN008Ref SO008Ref PDZ647Ref PDZ632Ref SN046Ref SN001Ref SO086Ref SO030Ref PDZ641Ref PDZ640Ref PDZ614Ref PDZ680Ref PDC550Ref PDZ616Ref PDZ618Ref SO072Ref PDC506Ref PDZ628Ref PDZ631Ref SN016Ref PDC547Ref SN039Ref PDC544Ref PDZ602Ref PDC533Ref PDZ683Ref PDZ673Ref PDZ612Ref PDC536Ref SO028Ref PDC541Ref PDZ677Ref SO070Ref PDC512Ref PDZ604Ref PDZ642Ref SN011Ref PDZ654Ref PDC528Ref SO044Ref SO039Ref SO031Ref PDC518Ref PDZ658Ref PDZ657Ref PDZ634Ref SN013Ref PDC534Ref PDZ652Ref PDC500Ref PDZ619Ref PDC502Ref SO007Ref PDZ685Ref PDC539Ref SO071Ref PDC538Ref SO032Ref PDC525Ref PDC511Ref PDZ646Ref SN035Ref SN043Ref PDC545Ref PDZ644Ref PDC531Ref SO034Ref PDZ648Ref PDZ655510(k) K003052Ref SO033Ref SN018Ref SO009Ref SO037Ref SN015Ref PDC501Ref PDZ650Ref PDZ686Ref SO017Ref PDZ672Ref PDZ661Ref PDZ609Ref PDC515Ref PDC504Ref PDC520

by NuMED, Inc.

Identity

Trade Name
Z-MED II EUDAMED
Tyshak II EUDAMED
Device Name
Z-MED II EUDAMED
Tyshak II EUDAMED
Model / Reference
305.1 EUDAMED
PDZ662 EUDAMED
105 EUDAMED
SO019 EUDAMED
PDC513 EUDAMED
PDZ638 EUDAMED
PDZ667 EUDAMED
SN044 EUDAMED
SO029 EUDAMED
PDC543 EUDAMED
PDZ600 EUDAMED
PDZ613 EUDAMED
SN033 EUDAMED
PDZ676 EUDAMED
PDZ617 EUDAMED
SO042 EUDAMED
PDC514 EUDAMED
PDZ625 EUDAMED
PDZ624 EUDAMED
PDZ666 EUDAMED
PDZ635 EUDAMED
SN034 EUDAMED
SO004 EUDAMED
SN010 EUDAMED
PDC526 EUDAMED
SO045 EUDAMED
PDC505 EUDAMED
PDC529 EUDAMED
SO001 EUDAMED
SN048 EUDAMED
PDC548 EUDAMED
SO002 EUDAMED
PDC522 EUDAMED
PDZ607 EUDAMED
PDC509 EUDAMED
SN008 EUDAMED
SO008 EUDAMED
PDZ647 EUDAMED
PDZ632 EUDAMED
SN046 EUDAMED
SN001 EUDAMED
SO086 EUDAMED
SO030 EUDAMED
PDZ641 EUDAMED
PDZ640 EUDAMED
PDZ614 EUDAMED
PDZ680 EUDAMED
PDC550 EUDAMED
PDZ616 EUDAMED
PDZ618 EUDAMED
SO072 EUDAMED
PDC506 EUDAMED
PDZ628 EUDAMED
PDZ631 EUDAMED
SN016 EUDAMED
PDC547 EUDAMED
SN039 EUDAMED
PDC544 EUDAMED
PDZ602 EUDAMED
PDC533 EUDAMED
PDZ683 EUDAMED
PDZ673 EUDAMED
PDZ612 EUDAMED
PDC536 EUDAMED
SO028 EUDAMED
PDC541 EUDAMED
PDZ677 EUDAMED
SO070 EUDAMED
PDC512 EUDAMED
PDZ604 EUDAMED
PDZ642 EUDAMED
SN011 EUDAMED
PDZ654 EUDAMED
PDC528 EUDAMED
SO044 EUDAMED
SO039 EUDAMED
SO031 EUDAMED
PDC518 EUDAMED
PDZ658 EUDAMED
PDZ657 EUDAMED
PDZ634 EUDAMED
SN013 EUDAMED
PDC534 EUDAMED
PDZ652 EUDAMED
PDC500 EUDAMED
PDZ619 EUDAMED
PDC502 EUDAMED
SO007 EUDAMED
PDZ685 EUDAMED
PDC539 EUDAMED
SO071 EUDAMED
PDC538 EUDAMED
SO032 EUDAMED
PDC525 EUDAMED
PDC511 EUDAMED
PDZ646 EUDAMED
SN035 EUDAMED
SN043 EUDAMED
PDC545 EUDAMED
PDZ644 EUDAMED
PDC531 EUDAMED
SO034 EUDAMED
PDZ648 EUDAMED
PDZ655 EUDAMED
SO033 EUDAMED
SN018 EUDAMED
SO009 EUDAMED
SO037 EUDAMED
SN015 EUDAMED
PDC501 EUDAMED
PDZ650 EUDAMED
PDZ686 EUDAMED
SO017 EUDAMED
PDZ672 EUDAMED
PDZ661 EUDAMED
PDZ609 EUDAMED
PDC515 EUDAMED
PDC504 EUDAMED
PDC520 EUDAMED

Identifiers

Primary DI / UDI-DI
10887714018210 EUDAMED
10887714012584 EUDAMED
10887714012560 EUDAMED
10887714017534 EUDAMED
10887714018357 EUDAMED
10887714017350 EUDAMED
10887714013185 EUDAMED
10887714012928 EUDAMED
10887714018760 EUDAMED
10887714019088 EUDAMED
10887714018036 EUDAMED
10887714018746 EUDAMED
10887714019187 EUDAMED
10887714018395 EUDAMED
10887714012577 EUDAMED
10887714019361 EUDAMED
10887714019347 EUDAMED
10887714018319 EUDAMED
10887714017411 EUDAMED
10887714017893 EUDAMED
10887714012485 EUDAMED
10887714013123 EUDAMED
10887714012720 EUDAMED
10887714018432 EUDAMED
10887714013239 EUDAMED
10887714012768 EUDAMED
10887714012355 EUDAMED
10887714017596 EUDAMED
10887714012980 EUDAMED
10887714012416 EUDAMED
10887714012676 EUDAMED
10887714018944 EUDAMED
10887714013130 EUDAMED
10887714013222 EUDAMED
10887714012423 EUDAMED
10887714017770 EUDAMED
10887714017299 EUDAMED
10887714017619 EUDAMED
10887714012782 EUDAMED
10887714012393 EUDAMED
10887714013208 EUDAMED
10887714017657 EUDAMED
10887714017633 EUDAMED
10887714019101 EUDAMED
10887714018487 EUDAMED
10887714013000 EUDAMED
10887714019163 EUDAMED
10887714019200 EUDAMED
10887714018685 EUDAMED
10887714012348 EUDAMED
10887714019446 EUDAMED
10887714017275 EUDAMED
10887714018562 EUDAMED
10887714012973 EUDAMED
10887714019026 EUDAMED
10887714012935 EUDAMED
10887714018821 EUDAMED
10887714012812 EUDAMED
10887714020800 EUDAMED
10887714018609 EUDAMED
10887714019064 EUDAMED
10887714012850 EUDAMED
10887714017374 EUDAMED
10887714012904 EUDAMED
10887714018647 EUDAMED
10887714018586 EUDAMED
10887714012553 EUDAMED
10887714018869 EUDAMED
10887714017671 EUDAMED
10887714013161 EUDAMED
10887714017930 EUDAMED
10887714012751 EUDAMED
10887714018272 EUDAMED
10887714017398 EUDAMED
10887714012362 EUDAMED
10887714012621 EUDAMED
10887714018067 EUDAMED
10887714018012 EUDAMED
10887714017336 EUDAMED
10887714012836 EUDAMED
10887714012829 EUDAMED
10887714017879 EUDAMED
10887714013031 EUDAMED
10887714019224 EUDAMED
10887714013086 EUDAMED
10887714013215 EUDAMED
10887714020848 EUDAMED
10887714012881 EUDAMED
10887714018623 EUDAMED
10887714012874 EUDAMED
10887714013192 EUDAMED
10887714012713 EUDAMED
10887714012546 EUDAMED
10887714017756 EUDAMED
10887714018081 EUDAMED
10887714017251 EUDAMED
10887714012942 EUDAMED
10887714017718 EUDAMED
10887714012799 EUDAMED
10887714012515 EUDAMED
10887714017794 EUDAMED
10887714017954 EUDAMED
10887714012478 EUDAMED
10887714018456 EUDAMED
10887714012379 EUDAMED
10887714012683 EUDAMED
10887714018142 EUDAMED
10887714013055 EUDAMED
10887714017831 EUDAMED
10887714020862 EUDAMED
10887714012409 EUDAMED
10887714018548 EUDAMED
10887714018180 EUDAMED
10887714018982 EUDAMED
10887714012591 EUDAMED
10887714013154 EUDAMED
10887714012652 EUDAMED
Basic UDI-DI
B-10887714018210 EUDAMED
B-10887714012584 EUDAMED
B-10887714012560 EUDAMED
B-10887714017534 EUDAMED
B-10887714018357 EUDAMED
B-10887714017350 EUDAMED
B-10887714013185 EUDAMED
B-10887714012928 EUDAMED
B-10887714018760 EUDAMED
B-10887714019088 EUDAMED
B-10887714018036 EUDAMED
B-10887714018746 EUDAMED
B-10887714019187 EUDAMED
B-10887714018395 EUDAMED
B-10887714012577 EUDAMED
B-10887714019361 EUDAMED
B-10887714019347 EUDAMED
B-10887714018319 EUDAMED
B-10887714017411 EUDAMED
B-10887714017893 EUDAMED
B-10887714012485 EUDAMED
B-10887714013123 EUDAMED
B-10887714012720 EUDAMED
B-10887714018432 EUDAMED
B-10887714013239 EUDAMED
B-10887714012768 EUDAMED
B-10887714012355 EUDAMED
B-10887714017596 EUDAMED
B-10887714012980 EUDAMED
B-10887714012416 EUDAMED
B-10887714012676 EUDAMED
B-10887714018944 EUDAMED
B-10887714013130 EUDAMED
B-10887714013222 EUDAMED
B-10887714012423 EUDAMED
B-10887714017770 EUDAMED
B-10887714017299 EUDAMED
B-10887714017619 EUDAMED
B-10887714012782 EUDAMED
B-10887714012393 EUDAMED
B-10887714013208 EUDAMED
B-10887714017657 EUDAMED
B-10887714017633 EUDAMED
B-10887714019101 EUDAMED
B-10887714018487 EUDAMED
B-10887714013000 EUDAMED
B-10887714019163 EUDAMED
B-10887714019200 EUDAMED
B-10887714018685 EUDAMED
B-10887714012348 EUDAMED
B-10887714019446 EUDAMED
B-10887714017275 EUDAMED
B-10887714018562 EUDAMED
B-10887714012973 EUDAMED
B-10887714019026 EUDAMED
B-10887714012935 EUDAMED
B-10887714018821 EUDAMED
B-10887714012812 EUDAMED
B-10887714020800 EUDAMED
B-10887714018609 EUDAMED
B-10887714019064 EUDAMED
B-10887714012850 EUDAMED
B-10887714017374 EUDAMED
B-10887714012904 EUDAMED
B-10887714018647 EUDAMED
B-10887714018586 EUDAMED
B-10887714012553 EUDAMED
B-10887714018869 EUDAMED
B-10887714017671 EUDAMED
B-10887714013161 EUDAMED
B-10887714017930 EUDAMED
B-10887714012751 EUDAMED
B-10887714018272 EUDAMED
B-10887714017398 EUDAMED
B-10887714012362 EUDAMED
B-10887714012621 EUDAMED
B-10887714018067 EUDAMED
B-10887714018012 EUDAMED
B-10887714017336 EUDAMED
B-10887714012836 EUDAMED
B-10887714012829 EUDAMED
B-10887714017879 EUDAMED
B-10887714013031 EUDAMED
B-10887714019224 EUDAMED
B-10887714013086 EUDAMED
B-10887714013215 EUDAMED
B-10887714020848 EUDAMED
B-10887714012881 EUDAMED
B-10887714018623 EUDAMED
B-10887714012874 EUDAMED
B-10887714013192 EUDAMED
B-10887714012713 EUDAMED
B-10887714012546 EUDAMED
B-10887714017756 EUDAMED
B-10887714018081 EUDAMED
B-10887714017251 EUDAMED
B-10887714012942 EUDAMED
B-10887714017718 EUDAMED
B-10887714012799 EUDAMED
B-10887714012515 EUDAMED
B-10887714017794 EUDAMED
B-10887714017954 EUDAMED
B-10887714012478 EUDAMED
B-10887714018456 EUDAMED
B-10887714012379 EUDAMED
B-10887714012683 EUDAMED
B-10887714018142 EUDAMED
B-10887714013055 EUDAMED
B-10887714017831 EUDAMED
B-10887714020862 EUDAMED
B-10887714012409 EUDAMED
B-10887714018548 EUDAMED
B-10887714018180 EUDAMED
B-10887714018982 EUDAMED
B-10887714012591 EUDAMED
B-10887714013154 EUDAMED
B-10887714012652 EUDAMED
510(k) Number
K003052 FDA 510(k)
FDA Product Code
LIT FDA 510(k)
EMDN Code
C019014 CARDIAC VALVULOPLASTY CATHETERS EUDAMED

Classification

Device Class
Class III EUDAMED
Class 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

United States Active

FDA_510K

European Union Active

CE/MDD

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 (118)

  • EUDAMED 39660311-9a22-46d2-88b4-f7a30003ee73 61 fields · synced Aug 4, 2026
  • EUDAMED 3eb444c4-2b5c-4777-ade6-2748d4eb486e 61 fields · synced May 11, 2026
  • EUDAMED 804e4e28-6490-466b-83af-a43b738e0af3 61 fields · synced May 11, 2026
  • EUDAMED a3a71652-0daf-45c5-be0f-c5b1e079b1fe 61 fields · synced May 11, 2026
  • EUDAMED b319b533-9160-499d-b8fb-2b20fc4eb111 61 fields · synced May 11, 2026
  • EUDAMED e02aea0b-94f9-4ab6-a381-5dc1c600f0c5 61 fields · synced May 11, 2026
  • EUDAMED 0ce7076e-bc55-4d78-a12f-066e40dfcbc4 61 fields · synced May 11, 2026
  • EUDAMED eb2aaa6a-5990-467b-807d-74ae97cd5bfb 61 fields · synced May 16, 2026
  • EUDAMED 815c7d66-b8b3-4f76-9fb7-b41ea5bd80c5 61 fields · synced May 16, 2026
  • EUDAMED 7abe647f-6673-4453-99af-2616250a6fa8 61 fields · synced May 16, 2026
  • EUDAMED 7f6de04f-db2a-492c-a363-75da560b21a5 61 fields · synced May 16, 2026
  • EUDAMED c9228211-a230-4435-94a6-2e6be9e49012 61 fields · synced May 16, 2026
  • EUDAMED 55558cfb-28cb-44f9-b25f-2ff2ba61a24a 61 fields · synced May 16, 2026
  • EUDAMED eddbd8db-81ad-45d2-8843-7cc7d6e47509 61 fields · synced May 16, 2026
  • EUDAMED 2bcc0224-b458-414c-b3a6-3747b38fa9a0 61 fields · synced May 16, 2026
  • EUDAMED 59b26bf9-cbe7-4ec2-94a0-efda1dcd235f 61 fields · synced May 16, 2026
  • EUDAMED 9184edb1-94d2-492f-abc4-29e37bd7602d 61 fields · synced May 16, 2026
  • EUDAMED 995b4b8b-c24b-4ffe-af7f-f4dcaea1a23e 61 fields · synced May 16, 2026
  • EUDAMED 0419ea68-93b9-420f-ac88-18733915d5ed 61 fields · synced May 16, 2026
  • EUDAMED 81d08f36-3224-4044-961d-ba3069d63267 61 fields · synced May 16, 2026
  • EUDAMED 3e6970e2-2639-4bf8-9ef9-27e8f5afb10f 61 fields · synced May 16, 2026
  • EUDAMED 0b554304-ed41-4bf6-96b7-9ad89823733e 61 fields · synced May 16, 2026
  • EUDAMED 929dd79b-6151-49e7-bb6a-73a58fb05687 61 fields · synced May 16, 2026
  • EUDAMED 588f7681-9967-4abc-84df-5ce0efc3b195 61 fields · synced May 16, 2026
  • EUDAMED d77d42d1-8895-4428-b337-f567770734bf 61 fields · synced May 16, 2026
  • EUDAMED f90e7313-e110-4bd2-8f22-e32c90d3eb4e 61 fields · synced May 16, 2026
  • EUDAMED 13cbad21-07d6-41dc-9684-92b634f53982 61 fields · synced May 16, 2026
  • EUDAMED b3992c6b-f55d-42ec-988e-f5a753749acf 61 fields · synced May 16, 2026
  • EUDAMED ea97182d-dc12-4ef3-a5ee-e36c3dca4b86 61 fields · synced May 16, 2026
  • EUDAMED 2947bade-8d63-4f31-b3c1-52f7b0d17881 61 fields · synced May 16, 2026
  • EUDAMED 98bbad37-aff2-4023-be11-73911678b0ca 61 fields · synced May 16, 2026
  • EUDAMED 423f2ddb-024e-46a8-abfd-ae8c5559b9f0 61 fields · synced May 17, 2026
  • EUDAMED 20ee3948-ca8e-4f7b-bf35-9a6fedca250a 61 fields · synced May 17, 2026
  • EUDAMED 45f0e6ae-3982-4e4e-8fab-73eb40f88c6c 61 fields · synced May 17, 2026
  • EUDAMED 9ac9dd93-e8c0-4fe9-ba70-7b4c4500e8bd 61 fields · synced May 17, 2026
  • EUDAMED c8553ca9-6996-404d-ac68-77040b4b0f18 61 fields · synced May 17, 2026
  • EUDAMED f95a56f8-b699-46e1-815e-38868e4970ba 61 fields · synced May 17, 2026
  • EUDAMED 6fd779cd-e6d7-4f06-ac6b-a66dfe1b049e 61 fields · synced May 17, 2026
  • EUDAMED 87c65a83-58f4-4fe6-904c-3fa11a0b8925 61 fields · synced May 17, 2026
  • EUDAMED 6e57a15f-330b-4439-b5da-3117818a8206 61 fields · synced May 17, 2026
  • EUDAMED fddac7fc-8005-4317-88c9-2d84a5384e9f 61 fields · synced May 17, 2026
  • EUDAMED 9ff3b86a-3e7e-4bc4-b376-e3168e115934 61 fields · synced May 17, 2026
  • EUDAMED 2fc665e1-fe70-40ff-9b58-6db2b0bcf36b 61 fields · synced May 17, 2026
  • EUDAMED 36bf2c96-57ef-4663-a3e3-e7d860cd076a 61 fields · synced May 17, 2026
  • EUDAMED 711dd074-4bd7-4eec-8d08-091601c4be80 61 fields · synced May 17, 2026
  • EUDAMED 9798fdf2-87f3-4e72-ade1-571f97c8dad0 61 fields · synced May 17, 2026
  • EUDAMED bbc5a822-4acd-41c6-b70d-3487ee52ca21 61 fields · synced May 17, 2026
  • EUDAMED 55b583c4-4808-4861-96e6-06e71f0b75da 61 fields · synced May 17, 2026
  • EUDAMED 342dbb6e-5df0-4186-a49a-e121ce7fd35f 61 fields · synced May 17, 2026
  • EUDAMED abf66226-29c5-416e-9cfc-89d546b992e5 61 fields · synced May 17, 2026
  • EUDAMED 27620b6a-72a1-452f-9b31-70ce3abc06a2 61 fields · synced May 17, 2026
  • EUDAMED 9a01114d-3fa8-4296-a76f-d2e817a90fe5 61 fields · synced May 17, 2026
  • EUDAMED 61aaedc8-1918-4aa3-b637-f744597fc750 61 fields · synced May 17, 2026
  • EUDAMED b3ed2ce3-c3ba-455b-aa31-9e39ac6bd533 61 fields · synced May 17, 2026
  • EUDAMED 3b6ad57f-0632-4dd2-a868-376097af960a 61 fields · synced May 17, 2026
  • EUDAMED d43519d4-c01f-4760-bb5f-0e57c576e346 61 fields · synced May 17, 2026
  • EUDAMED 281f9abd-7228-4888-9921-e906a4e34a7c 61 fields · synced May 17, 2026
  • EUDAMED 4c902046-74e5-41ec-899d-65c9859242be 61 fields · synced May 17, 2026
  • EUDAMED ead5d063-fbd0-4369-9303-775748efa6f6 61 fields · synced May 17, 2026
  • EUDAMED 21ae82f2-d09e-4338-b2ee-d6ea0194cb9a 61 fields · synced May 17, 2026
  • EUDAMED dd6fb981-c7d9-4039-989c-c1323d5a37c0 61 fields · synced May 17, 2026
  • EUDAMED 25c447c1-1fe9-4585-9263-e597dfa1a80d 61 fields · synced May 17, 2026
  • EUDAMED 29efc416-ae37-4c6e-af5c-da8bbad1ab90 61 fields · synced May 17, 2026
  • EUDAMED 88cf4ea9-fc72-4d9d-93f5-3dc57d40d1ab 61 fields · synced May 17, 2026
  • EUDAMED d4a7aeb3-3ac9-4a73-892d-3591d6cdcb65 61 fields · synced May 17, 2026
  • EUDAMED c484ca4a-99d3-4e78-b482-3451262c4736 61 fields · synced May 17, 2026
  • EUDAMED 0b24935c-5485-4a22-8e7b-78cf1f5b159a 61 fields · synced May 17, 2026
  • EUDAMED 628a970f-3ca4-401c-8e1b-e6f4edc68913 61 fields · synced May 17, 2026
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