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Soldier

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref S22-SP-130Ref S27-SP-155510(k) K232536Ref S22-SP-155

by Embolx, Inc.

Identity

Trade Name
Soldier EUDAMED
Device Name
Soldier High Flow Microcatheter EUDAMED
Model / Reference
S22-SP-130 EUDAMED
S27-SP-155 EUDAMED
S22-SP-155 EUDAMED

Identifiers

Primary DI / UDI-DI
00853359008148 EUDAMED
00853359008193 EUDAMED
00853359008155 EUDAMED
Basic UDI-DI
B-00853359008148 EUDAMED
B-00853359008193 EUDAMED
B-00853359008155 EUDAMED
510(k) Number
K232536 FDA 510(k)
FDA Product Code
DQO FDA 510(k)
EMDN Code
C01050202 PTA EMBOLIC PROTECTION CATHETERS AND SYSTEMS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1200 FDA 510(k)
Regulation Number
870.1200 FDA 510(k)
Market of Registration
France 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

Soldier by Embolx, Inc. — Class IIa — 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
Embolx, Inc.
EUDAMED SRN
US-MF-000025650
Authorised Representative
MDSS GmbH DE-AR-000005430

Sources (4)

  • EUDAMED 99f42c65-85d6-44f0-af49-532ab9f79831 61 fields · synced Jul 19, 2026
  • EUDAMED e2110703-df2b-47d7-a086-eda1d8573a14 61 fields · synced May 18, 2026
  • FDA 510(k) K232536 24 fields · synced May 18, 2026
  • EUDAMED ba59307b-8cb1-4ad0-98e2-b001d3a51245 61 fields · synced Jul 8, 2026