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Tyshak

EUDAMEDFDA 510(k)

Class III (EU MDR)

Ref PDC140Model 102Ref PDC155Ref PDC015Ref PDC185Ref PDC180Ref PDC162Ref PDC022Ref PDC176Ref PDC031Ref PDC059Ref PDC021Ref PDC186Ref PDC009Ref PDC054Ref PDC167Ref PDC097Ref PDC064Ref PDC117Ref PDC159Ref PDC138Ref PDC170Ref PDC037Ref PDC092Ref PDC014Ref PDC088Ref PDC045Ref PDC199Ref PDC080Ref PDC146Ref PDC183Ref PDC171Ref PDC177Ref PDC135Ref PDC193Ref PDC085Ref PDC011Ref PDC017Ref PDC150Ref PDC042Ref PDC137Ref PDC006Ref PDC129Ref PDC003Ref PDC041Ref PDC110Ref PDC184Ref PDC102Ref PDC107Ref PDC123Ref PDC172Ref PDC175Ref PDC062Ref PDC141Ref PDC195Ref PDC145Ref PDC192Ref PDC111Ref PDC194Ref PDC198Ref PDC149Ref PDC113Ref PDC153Ref PDC114Ref PDC174Ref PDC040Ref SO010Ref PDC077Ref PDC028Ref PDC070Ref PDC187Ref PDC148Ref PDC168Ref PDC091Ref PDC074Ref PDC131Ref PDC002Ref PDC026Ref PDC109Ref PDC139Ref PDC120510(k) K003114Ref PDC073Ref PDC122Ref PDC056Ref SO011Ref PDC053Ref PDC035Ref PDC082Ref PDC050Ref PDC010Ref PDC132Ref PDC130Ref PDC196Ref PDC100Ref PDC005Ref PDC163Ref PDC124Ref PDC094Ref PDC061

by NuMED, Inc.

Identity

Trade Name
Tyshak EUDAMED
Device Name
Tyshak EUDAMED
Model / Reference
102 EUDAMED
PDC140 EUDAMED
PDC155 EUDAMED
PDC015 EUDAMED
PDC185 EUDAMED
PDC180 EUDAMED
PDC162 EUDAMED
PDC022 EUDAMED
PDC176 EUDAMED
PDC031 EUDAMED
PDC059 EUDAMED
PDC021 EUDAMED
PDC186 EUDAMED
PDC009 EUDAMED
PDC054 EUDAMED
PDC167 EUDAMED
PDC097 EUDAMED
PDC064 EUDAMED
PDC117 EUDAMED
PDC159 EUDAMED
PDC138 EUDAMED
PDC170 EUDAMED
PDC037 EUDAMED
PDC092 EUDAMED
PDC014 EUDAMED
PDC088 EUDAMED
PDC045 EUDAMED
PDC199 EUDAMED
PDC080 EUDAMED
PDC146 EUDAMED
PDC183 EUDAMED
PDC171 EUDAMED
PDC177 EUDAMED
PDC135 EUDAMED
PDC193 EUDAMED
PDC085 EUDAMED
PDC011 EUDAMED
PDC017 EUDAMED
PDC150 EUDAMED
PDC042 EUDAMED
PDC137 EUDAMED
PDC006 EUDAMED
PDC129 EUDAMED
PDC003 EUDAMED
PDC041 EUDAMED
PDC110 EUDAMED
PDC184 EUDAMED
PDC102 EUDAMED
PDC107 EUDAMED
PDC123 EUDAMED
PDC172 EUDAMED
PDC175 EUDAMED
PDC062 EUDAMED
PDC141 EUDAMED
PDC195 EUDAMED
PDC145 EUDAMED
PDC192 EUDAMED
PDC111 EUDAMED
PDC194 EUDAMED
PDC198 EUDAMED
PDC149 EUDAMED
PDC113 EUDAMED
PDC153 EUDAMED
PDC114 EUDAMED
PDC174 EUDAMED
PDC040 EUDAMED
SO010 EUDAMED
PDC077 EUDAMED
PDC028 EUDAMED
PDC070 EUDAMED
PDC187 EUDAMED
PDC148 EUDAMED
PDC168 EUDAMED
PDC091 EUDAMED
PDC074 EUDAMED
PDC131 EUDAMED
PDC002 EUDAMED
PDC026 EUDAMED
PDC109 EUDAMED
PDC139 EUDAMED
PDC120 EUDAMED
PDC073 EUDAMED
PDC122 EUDAMED
PDC056 EUDAMED
SO011 EUDAMED
PDC053 EUDAMED
PDC035 EUDAMED
PDC082 EUDAMED
PDC050 EUDAMED
PDC010 EUDAMED
PDC132 EUDAMED
PDC130 EUDAMED
PDC196 EUDAMED
PDC100 EUDAMED
PDC005 EUDAMED
PDC163 EUDAMED
PDC124 EUDAMED
PDC094 EUDAMED
PDC061 EUDAMED

Identifiers

Primary DI / UDI-DI
10887714011303 EUDAMED
10887714012072 EUDAMED
10887714010672 EUDAMED
10887714010542 EUDAMED
10887714012119 EUDAMED
10887714011198 EUDAMED
10887714011587 EUDAMED
10887714011815 EUDAMED
10887714011952 EUDAMED
10887714011044 EUDAMED
10887714011501 EUDAMED
10887714010481 EUDAMED
10887714012096 EUDAMED
10887714010399 EUDAMED
10887714010511 EUDAMED
10887714011105 EUDAMED
10887714010214 EUDAMED
10887714010245 EUDAMED
10887714010450 EUDAMED
10887714011525 EUDAMED
10887714010627 EUDAMED
10887714011860 EUDAMED
10887714010948 EUDAMED
10887714010603 EUDAMED
10887714011648 EUDAMED
10887714011907 EUDAMED
10887714011280 EUDAMED
10887714010269 EUDAMED
10887714010412 EUDAMED
10887714010405 EUDAMED
10887714010658 EUDAMED
10887714011891 EUDAMED
10887714011150 EUDAMED
10887714010832 EUDAMED
10887714011259 EUDAMED
10887714010283 EUDAMED
10887714011075 EUDAMED
10887714010443 EUDAMED
10887714011211 EUDAMED
10887714011181 EUDAMED
10887714011778 EUDAMED
10887714010436 EUDAMED
10887714011570 EUDAMED
10887714011112 EUDAMED
10887714010290 EUDAMED
10887714010528 EUDAMED
10887714011747 EUDAMED
10887714010801 EUDAMED
10887714011037 EUDAMED
10887714011518 EUDAMED
10887714011785 EUDAMED
10887714011655 EUDAMED
10887714011532 EUDAMED
10887714010955 EUDAMED
10887714011426 EUDAMED
10887714010818 EUDAMED
10887714011327 EUDAMED
10887714010962 EUDAMED
10887714011235 EUDAMED
10887714010566 EUDAMED
10887714012089 EUDAMED
10887714010825 EUDAMED
10887714010191 EUDAMED
10887714011679 EUDAMED
10887714010900 EUDAMED
10887714010726 EUDAMED
10887714011457 EUDAMED
10887714011273 EUDAMED
10887714010849 EUDAMED
10887714010634 EUDAMED
10887714010474 EUDAMED
10887714010641 EUDAMED
10887714010719 EUDAMED
10887714010429 EUDAMED
10887714011396 EUDAMED
10887714011549 EUDAMED
10887714012126 EUDAMED
10887714011808 EUDAMED
10887714011402 EUDAMED
10887714011419 EUDAMED
10887714011556 EUDAMED
10887714011082 EUDAMED
10887714010696 EUDAMED
10887714012010 EUDAMED
10887714010313 EUDAMED
10887714011600 EUDAMED
10887714011464 EUDAMED
10887714011754 EUDAMED
10887714010207 EUDAMED
10887714010351 EUDAMED
10887714010238 EUDAMED
10887714010979 EUDAMED
10887714011310 EUDAMED
10887714011686 EUDAMED
10887714010252 EUDAMED
10887714011822 EUDAMED
10887714011051 EUDAMED
10887714011631 EUDAMED
Basic UDI-DI
B-10887714011303 EUDAMED
B-10887714012072 EUDAMED
B-10887714010672 EUDAMED
B-10887714010542 EUDAMED
B-10887714012119 EUDAMED
B-10887714011198 EUDAMED
B-10887714011587 EUDAMED
B-10887714011815 EUDAMED
B-10887714011952 EUDAMED
B-10887714011044 EUDAMED
B-10887714011501 EUDAMED
B-10887714010481 EUDAMED
B-10887714012096 EUDAMED
B-10887714010399 EUDAMED
B-10887714010511 EUDAMED
B-10887714011105 EUDAMED
B-10887714010214 EUDAMED
B-10887714010245 EUDAMED
B-10887714010450 EUDAMED
B-10887714011525 EUDAMED
B-10887714010627 EUDAMED
B-10887714011860 EUDAMED
B-10887714010948 EUDAMED
B-10887714010603 EUDAMED
B-10887714011648 EUDAMED
B-10887714011907 EUDAMED
B-10887714011280 EUDAMED
B-10887714010269 EUDAMED
B-10887714010412 EUDAMED
B-10887714010405 EUDAMED
B-10887714010658 EUDAMED
B-10887714011891 EUDAMED
B-10887714011150 EUDAMED
B-10887714010832 EUDAMED
B-10887714011259 EUDAMED
B-10887714010283 EUDAMED
B-10887714011075 EUDAMED
B-10887714010443 EUDAMED
B-10887714011211 EUDAMED
B-10887714011181 EUDAMED
B-10887714011778 EUDAMED
B-10887714010436 EUDAMED
B-10887714011570 EUDAMED
B-10887714011112 EUDAMED
B-10887714010290 EUDAMED
B-10887714010528 EUDAMED
B-10887714011747 EUDAMED
B-10887714010801 EUDAMED
B-10887714011037 EUDAMED
B-10887714011518 EUDAMED
B-10887714011785 EUDAMED
B-10887714011655 EUDAMED
B-10887714011532 EUDAMED
B-10887714010955 EUDAMED
B-10887714011426 EUDAMED
B-10887714010818 EUDAMED
B-10887714011327 EUDAMED
B-10887714010962 EUDAMED
B-10887714011235 EUDAMED
B-10887714010566 EUDAMED
B-10887714012089 EUDAMED
B-10887714010825 EUDAMED
B-10887714010191 EUDAMED
B-10887714011679 EUDAMED
B-10887714010900 EUDAMED
B-10887714010726 EUDAMED
B-10887714011457 EUDAMED
B-10887714011273 EUDAMED
B-10887714010849 EUDAMED
B-10887714010634 EUDAMED
B-10887714010474 EUDAMED
B-10887714010641 EUDAMED
B-10887714010719 EUDAMED
B-10887714010429 EUDAMED
B-10887714011396 EUDAMED
B-10887714011549 EUDAMED
B-10887714012126 EUDAMED
B-10887714011808 EUDAMED
B-10887714011402 EUDAMED
B-10887714011419 EUDAMED
B-10887714011556 EUDAMED
B-10887714011082 EUDAMED
B-10887714010696 EUDAMED
B-10887714012010 EUDAMED
B-10887714010313 EUDAMED
B-10887714011600 EUDAMED
B-10887714011464 EUDAMED
B-10887714011754 EUDAMED
B-10887714010207 EUDAMED
B-10887714010351 EUDAMED
B-10887714010238 EUDAMED
B-10887714010979 EUDAMED
B-10887714011310 EUDAMED
B-10887714011686 EUDAMED
B-10887714010252 EUDAMED
B-10887714011822 EUDAMED
B-10887714011051 EUDAMED
B-10887714011631 EUDAMED
510(k) Number
K003114 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

Tyshak 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

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 (99)

  • EUDAMED 4c4b5000-6efd-4144-8736-ceb833506796 61 fields · synced Aug 3, 2026
  • EUDAMED 66710c2f-18b5-4b9f-b6f1-7787c2f3e231 61 fields · synced May 11, 2026
  • EUDAMED 883a30d5-b24a-4348-8902-87fa3716f02c 61 fields · synced May 11, 2026
  • EUDAMED 084cdf45-251a-4782-8294-6aca376897dd 61 fields · synced May 11, 2026
  • EUDAMED 18fe4058-2cf3-43b6-bd71-2235a2389925 61 fields · synced May 11, 2026
  • EUDAMED b5ae7b54-aed9-4afd-9c69-41d05f137e4e 61 fields · synced May 16, 2026
  • EUDAMED 5b0c689e-2aa7-4da9-bb68-afc1fe2ded69 61 fields · synced May 16, 2026
  • EUDAMED 093be1d0-2b5c-4b1b-a09f-e71f1881135e 61 fields · synced May 16, 2026
  • EUDAMED 98afda75-1275-4fee-9a7e-a79973f55580 61 fields · synced May 16, 2026
  • EUDAMED 6d77c890-3390-418d-9faa-68eee0575b9f 61 fields · synced May 16, 2026
  • EUDAMED f73a415f-57ae-49d5-981a-04712de72623 61 fields · synced May 16, 2026
  • EUDAMED e64c8a43-3eff-48ea-bc2a-cd8514d0a1c2 61 fields · synced May 16, 2026
  • EUDAMED fb5aa6b2-933a-450e-85e0-60cad98a8b98 61 fields · synced May 16, 2026
  • EUDAMED 9c080756-3152-4906-8652-26b7d67277cb 61 fields · synced May 16, 2026
  • EUDAMED 9f3604df-e489-4b92-b3e3-29ccf8ff69c6 61 fields · synced May 16, 2026
  • EUDAMED 5399e97f-4931-4f45-94b1-c0dc5b4c099d 61 fields · synced May 16, 2026
  • EUDAMED f12489c9-7a1a-4182-8d88-3921982b1862 61 fields · synced May 16, 2026
  • EUDAMED ffb88f3e-ce34-4a8a-a098-1ec72252aa64 61 fields · synced May 16, 2026
  • EUDAMED c17cd3dd-05da-4a66-9aa3-2f022ea6b987 61 fields · synced May 16, 2026
  • EUDAMED 41669187-d918-46b0-a4ca-5e9aca19c430 61 fields · synced May 17, 2026
  • EUDAMED 6f8a853b-1847-488c-afde-ff7e5ead0322 61 fields · synced May 17, 2026
  • EUDAMED 40589b11-964f-46b5-9093-4ee3b779fc63 61 fields · synced May 17, 2026
  • EUDAMED 4a8e7677-f268-4394-b29d-a50d184814a4 61 fields · synced May 17, 2026
  • EUDAMED a8cfc8b8-7274-4abc-92ab-646d9099713a 61 fields · synced May 17, 2026
  • EUDAMED d802fd71-bb02-42a8-a845-1c34991bd3c0 61 fields · synced May 17, 2026
  • EUDAMED 9571fb4d-9fb9-412e-a437-e2e2b8d7eea5 61 fields · synced May 17, 2026
  • EUDAMED 27d9c690-05fa-4ceb-9b69-500ec055ea7e 61 fields · synced May 17, 2026
  • EUDAMED e07dcc26-4f5e-4423-99df-01b826fd4579 61 fields · synced May 17, 2026
  • EUDAMED 6b29de1e-f0f2-436e-9e91-aeb0a66f7e5e 61 fields · synced May 17, 2026
  • EUDAMED b7ebb0af-4c49-4372-9d61-420378a8db92 61 fields · synced May 17, 2026
  • EUDAMED 5287f428-9b49-4a03-a23f-e80868b36073 61 fields · synced May 17, 2026
  • EUDAMED cc840114-1385-466f-a61a-4807676da653 61 fields · synced May 17, 2026
  • EUDAMED 8db3ca4d-e970-43b0-8072-e5655288b96d 61 fields · synced May 17, 2026
  • EUDAMED a6f31bf3-8db2-4033-851e-60cb8f28d1a4 61 fields · synced May 17, 2026
  • EUDAMED 27687b0d-9696-4a33-9f12-4f3aec2138df 61 fields · synced May 17, 2026
  • EUDAMED a5ca4cf1-fd4e-4063-8224-cac8b1a16954 61 fields · synced May 17, 2026
  • EUDAMED cc5af014-1d9e-4d06-a945-8128affea8dc 61 fields · synced May 17, 2026
  • EUDAMED 12438459-75fb-4e06-806b-d7b3f94b8cfb 61 fields · synced May 17, 2026
  • EUDAMED 7a18b110-1450-4c2b-bb97-b674e25957a9 61 fields · synced May 17, 2026
  • EUDAMED b7267ffc-5851-404e-ab00-530a297d64e8 61 fields · synced May 17, 2026
  • EUDAMED 20cf2c9e-ca8d-4569-bdf9-9ed8db94cf7d 61 fields · synced May 17, 2026
  • EUDAMED 42822aab-7fc4-411e-8c88-0cd29d8bb1c2 61 fields · synced May 17, 2026
  • EUDAMED 4c2a4261-8a02-4c64-ad9c-0a03752e3ecd 61 fields · synced May 17, 2026
  • EUDAMED ffb27187-155b-4a33-b466-7fe7e9ca268d 61 fields · synced May 17, 2026
  • EUDAMED 2f6cc83c-d5e7-4322-b627-bca2d5f11eae 61 fields · synced May 17, 2026
  • EUDAMED 3ae2c351-d870-4850-8278-b393fb38ca25 61 fields · synced May 17, 2026
  • EUDAMED 7e244a8d-aee3-4b52-b6df-62e8e078aabf 61 fields · synced May 17, 2026
  • EUDAMED c535e303-959e-41ed-903b-d9478c64b37f 61 fields · synced May 17, 2026
  • EUDAMED 779131d1-3423-424f-8b2a-b249943c535b 61 fields · synced May 17, 2026
  • EUDAMED 0a75ccc6-11b1-4fe4-934a-b20701f341bf 61 fields · synced May 17, 2026
  • EUDAMED 289969d2-e32d-4d0a-ac96-75359f4edc2a 61 fields · synced May 17, 2026
  • EUDAMED c3cb282b-c811-40c4-b28a-4e1643f32eae 61 fields · synced May 18, 2026
  • EUDAMED b8c96e07-e861-4330-976f-1b269d285142 61 fields · synced May 18, 2026
  • EUDAMED 1b883795-21ac-41e2-b171-aff214ec4f0f 61 fields · synced May 18, 2026
  • EUDAMED db6dbd71-fcda-466b-bf3f-1f3e71d32258 61 fields · synced May 18, 2026
  • EUDAMED 88e05d76-d1b2-44ae-8800-48babb3a12f0 61 fields · synced May 18, 2026
  • EUDAMED 3fa6968f-871b-471c-b05f-ba2646507c05 61 fields · synced May 18, 2026
  • EUDAMED 5829cd3d-2eb8-4f90-8053-76e36f853889 61 fields · synced May 18, 2026
  • EUDAMED 52f734bd-b453-402a-a2a0-162e26495f79 61 fields · synced May 18, 2026
  • EUDAMED 1e5d4f6d-86b6-4168-b0a5-91d6f277953e 61 fields · synced May 18, 2026
  • EUDAMED 9e322cf4-c71c-4f8b-b216-3a2da56f2a39 61 fields · synced May 18, 2026
  • EUDAMED d33f7c98-8750-4676-a95f-9e9dae3ec78e 61 fields · synced May 18, 2026
  • EUDAMED 9c4461c7-28ab-4f35-be80-f57a9897a064 61 fields · synced May 18, 2026
  • EUDAMED d76565fa-6713-49be-9d5f-0c5d6aa65115 61 fields · synced May 18, 2026
  • EUDAMED f25f02cb-b51c-4c89-a478-90a5e56ee1a4 61 fields · synced May 18, 2026
  • EUDAMED e4c20f76-a464-4248-961d-d9a4936fe682 61 fields · synced May 18, 2026
  • EUDAMED b93547de-e14c-4abe-a036-2419f20941cd 61 fields · synced May 18, 2026
  • EUDAMED 453307c9-9f58-4616-8fe8-5340e20f0e77 61 fields · synced May 18, 2026
  • EUDAMED b27d2fb3-0c1f-42a9-b8a6-db6b20831513 61 fields · synced May 18, 2026
  • EUDAMED 529de6ec-9f73-47a7-bde8-38a694e15640 61 fields · synced May 18, 2026
  • EUDAMED 2bfe0f3b-46c0-475b-ab63-85c9d15f0795 61 fields · synced May 18, 2026
  • EUDAMED 9827626d-2bfb-491b-9f71-22950c64e088 61 fields · synced May 18, 2026
  • EUDAMED 56e7acda-a14d-4c01-8c63-22453d3fb1cf 61 fields · synced May 18, 2026
  • EUDAMED d93eb9cf-1559-4668-b346-290c24a99b86 61 fields · synced May 18, 2026
  • EUDAMED 1cc2e730-f094-4c7f-8e29-5dc38fe6e0d4 61 fields · synced May 18, 2026
  • EUDAMED d5ce328b-9ac8-4338-997c-3906e2852661 61 fields · synced May 18, 2026
  • EUDAMED 79056c9e-727c-4b1e-88ea-f5be8c131ae4 61 fields · synced May 18, 2026
  • EUDAMED c2d91715-2991-4740-9da7-6a4ba2327895 61 fields · synced May 18, 2026
  • EUDAMED 8e4973a4-047d-453b-910e-da9b5ff9f1de 61 fields · synced May 18, 2026
  • EUDAMED ef8672e0-c68f-4a92-bad7-2656cda0bef6 61 fields · synced May 18, 2026
  • FDA 510(k) K003114 24 fields · synced May 18, 2026
  • EUDAMED ee3daae4-5744-4b7c-803a-5f8b12ea5d31 61 fields · synced Jun 20, 2026
  • EUDAMED b712c11b-242d-4775-bfbd-2bef7dfc0c42 61 fields · synced Jul 9, 2026
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  • EUDAMED cbf28fe2-0c72-4a95-931e-f9d2c278db89 61 fields · synced Jul 9, 2026
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