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Sterlink

EUDAMEDFDA 510(k)

Class IIb (EU MDR)

Ref STERLINKModel FPS-15s Plus510(k) K223015

by Plasmapp Co., Ltd

Identity

Model / Reference
FPS-15s Plus EUDAMED
STERLINK EUDAMED

Identifiers

Primary DI / UDI-DI
08800066500276 EUDAMED
Basic UDI-DI
88000665PLASTPEU8Y EUDAMED
510(k) Number
K223015 FDA 510(k)
FDA Product Code
MLR FDA 510(k)
EMDN Code
S900199 DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER EUDAMED

Classification

Device Class
Class IIb EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.6860 FDA 510(k)
Regulation Number
880.6860 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

CMR Substance

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Endocrine Disruptor

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

No

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Sterlink by Plasmapp Co., Ltd. — Class IIb — MDD, FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDD

United States Active

FDA_510K

European Union Active

CE/MDR

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Manufacturer

Manufacturer
Plasmapp Co., Ltd
EUDAMED SRN
KR-MF-000012193
Authorised Representative
MedNet EC-REP GmbH DE-AR-000000002

Sources (2)

  • EUDAMED a6c59349-0b42-4da4-9eb6-e117a15580ea 61 fields · synced Jul 26, 2026
  • FDA 510(k) K223015 24 fields · synced May 18, 2026