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COEfficient

EUDAMEDFDA 510(k)

Class III (EU MDR)

Ref COE139Model 303Ref COE101Ref COE152Ref COE135Ref COE115Ref COE110Ref COE121Ref COE103Ref SN032Ref COE124Ref COE149Ref COE131Ref COE143Ref COE117Ref COE129Ref COE132Ref COE148Ref COE125Ref COE137Ref COE118Ref COE154Ref COE136510(k) K014124Ref COE130Ref COE120Ref COE107Ref COE153Ref COE142Ref COE104Ref COE147Ref COE128Ref COE144Ref COE122

by NuMED, Inc.

Identity

Trade Name
COEfficient EUDAMED
Device Name
COEfficient EUDAMED
Model / Reference
303 EUDAMED
COE139 EUDAMED
COE101 EUDAMED
COE152 EUDAMED
COE135 EUDAMED
COE115 EUDAMED
COE110 EUDAMED
COE121 EUDAMED
COE103 EUDAMED
SN032 EUDAMED
COE124 EUDAMED
COE149 EUDAMED
COE131 EUDAMED
COE143 EUDAMED
COE117 EUDAMED
COE129 EUDAMED
COE132 EUDAMED
COE148 EUDAMED
COE125 EUDAMED
COE137 EUDAMED
COE118 EUDAMED
COE154 EUDAMED
COE136 EUDAMED
COE130 EUDAMED
COE120 EUDAMED
COE107 EUDAMED
COE153 EUDAMED
COE142 EUDAMED
COE104 EUDAMED
COE147 EUDAMED
COE128 EUDAMED
COE144 EUDAMED
COE122 EUDAMED

Identifiers

Primary DI / UDI-DI
10887714003070 EUDAMED
10887714002936 EUDAMED
10887714002752 EUDAMED
10887714002677 EUDAMED
10887714003490 EUDAMED
10887714003292 EUDAMED
10887714002653 EUDAMED
10887714003018 EUDAMED
10887714003513 EUDAMED
10887714002776 EUDAMED
10887714002592 EUDAMED
10887714003278 EUDAMED
10887714003315 EUDAMED
10887714003599 EUDAMED
10887714003032 EUDAMED
10887714003391 EUDAMED
10887714003612 EUDAMED
10887714002813 EUDAMED
10887714002950 EUDAMED
10887714003636 EUDAMED
10887714002875 EUDAMED
10887714002790 EUDAMED
10887714003155 EUDAMED
10887714002615 EUDAMED
10887714003179 EUDAMED
10887714002837 EUDAMED
10887714003230 EUDAMED
10887714003056 EUDAMED
10887714003575 EUDAMED
10887714002912 EUDAMED
10887714003353 EUDAMED
10887714002691 EUDAMED
Basic UDI-DI
B-10887714003070 EUDAMED
B-10887714002936 EUDAMED
B-10887714002752 EUDAMED
B-10887714002677 EUDAMED
B-10887714003490 EUDAMED
B-10887714003292 EUDAMED
B-10887714002653 EUDAMED
B-10887714003018 EUDAMED
B-10887714003513 EUDAMED
B-10887714002776 EUDAMED
B-10887714002592 EUDAMED
B-10887714003278 EUDAMED
B-10887714003315 EUDAMED
B-10887714003599 EUDAMED
B-10887714003032 EUDAMED
B-10887714003391 EUDAMED
B-10887714003612 EUDAMED
B-10887714002813 EUDAMED
B-10887714002950 EUDAMED
B-10887714003636 EUDAMED
B-10887714002875 EUDAMED
B-10887714002790 EUDAMED
B-10887714003155 EUDAMED
B-10887714002615 EUDAMED
B-10887714003179 EUDAMED
B-10887714002837 EUDAMED
B-10887714003230 EUDAMED
B-10887714003056 EUDAMED
B-10887714003575 EUDAMED
B-10887714002912 EUDAMED
B-10887714003353 EUDAMED
B-10887714002691 EUDAMED
510(k) Number
K014124 FDA 510(k)
FDA Product Code
OMZ 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

COEfficient 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

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Manufacturer

Manufacturer
NuMED, Inc.
EUDAMED SRN
US-MF-000010948
Authorised Representative
EVOMED S.L.U. ES-AR-000047116

Sources (33)

  • EUDAMED 081f56b2-f7fb-4818-ad27-120d274a13b0 61 fields · synced Sep 18, 2026
  • EUDAMED a6cf6f59-ec7b-4394-a66d-e6f15d48526d 61 fields · synced May 11, 2026
  • EUDAMED 70031ef3-9290-4efb-9a8d-9ecb6a9f5548 61 fields · synced May 16, 2026
  • EUDAMED ae407cd1-6346-4c36-a593-a0764a8abdf8 61 fields · synced May 16, 2026
  • EUDAMED 1ff3d03d-29fd-4e3c-9a04-ddb6236efb3c 61 fields · synced May 16, 2026
  • EUDAMED b9287968-e2a3-4703-9a1c-7f3ad2277db2 61 fields · synced May 16, 2026
  • EUDAMED 214eeecc-75c2-46ad-8f95-f2f12bfceec7 61 fields · synced May 16, 2026
  • EUDAMED c3fb8efd-f6bc-45e2-a6bd-51cfa31e1479 61 fields · synced May 17, 2026
  • EUDAMED efe131e3-8f0a-419a-b845-61c7bdc1ba9c 61 fields · synced May 17, 2026
  • EUDAMED b5aa89eb-03c1-446d-8e85-1ee45144e49b 61 fields · synced May 17, 2026
  • EUDAMED 936e9fd8-18db-43a2-b5fa-c1b7a54c589a 61 fields · synced May 17, 2026
  • EUDAMED 9e2b9978-8d97-48d6-8e40-ebcc09c3360f 61 fields · synced May 17, 2026
  • EUDAMED 59df44ee-0b71-4e4f-af4e-95c7a91a110c 61 fields · synced May 17, 2026
  • EUDAMED 8ccc4f2b-d720-482d-892e-5b9669768644 61 fields · synced May 17, 2026
  • EUDAMED 4ecee0be-c9cf-4ff9-a235-72563cfc4a78 61 fields · synced May 17, 2026
  • EUDAMED f59cdf8c-ab2c-402d-ba65-23986cdd7d8e 61 fields · synced May 18, 2026
  • EUDAMED 33bbe357-3ab3-4d2e-aa59-f18aa73d008d 61 fields · synced May 18, 2026
  • EUDAMED e90bd5df-5531-4d7f-a919-233f80eeea31 61 fields · synced May 18, 2026
  • EUDAMED 7b9db587-2965-4164-a46d-e460ef9fa90f 61 fields · synced May 18, 2026
  • EUDAMED fe7c8d2b-7192-485f-8a27-d78c81785665 61 fields · synced May 18, 2026
  • EUDAMED f6fc904f-dca3-46f5-b084-c16a36a1352f 61 fields · synced May 18, 2026
  • EUDAMED 54ea88ec-a8fb-408d-a84d-36d5edec75ec 61 fields · synced May 18, 2026
  • FDA 510(k) K014124 24 fields · synced May 18, 2026
  • EUDAMED 8b821643-6bb1-4535-8abc-e411031be356 61 fields · synced Jul 9, 2026
  • EUDAMED 4f855630-5074-4966-a478-f35b281c475d 61 fields · synced Jul 9, 2026
  • EUDAMED 389d83a2-a132-4957-a500-5ffb860349a0 61 fields · synced Jul 12, 2026
  • EUDAMED 296642bc-eea5-4c37-a118-bb90dcc5d614 61 fields · synced Jul 12, 2026
  • EUDAMED 217e50de-c8cf-44c7-9803-820a41170c3f 61 fields · synced Jul 14, 2026
  • EUDAMED d5b58429-a8cd-47ea-b9e8-59624c2ad0f7 61 fields · synced Jul 17, 2026
  • EUDAMED 6cb3fec1-f2b2-46cb-b36c-c030533b46c3 61 fields · synced Jul 21, 2026
  • EUDAMED eaed34e6-2f5a-4c69-8bb8-7a8df6c71684 61 fields · synced Jul 22, 2026
  • EUDAMED cfd65287-d044-411b-8ab9-a80291654bc0 61 fields · synced Jul 28, 2026
  • EUDAMED 5f392572-20f3-4507-9b03-af43f9c41b49 61 fields · synced Jul 31, 2026