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STERLINK Plus FPS-15s Plus

by Plasmapp Co., Ltd

Ref STERLINKModel FPS-15s Plus510(k) K231169

STERLINK Plus FPS-15s Plus is a device classified as Class IIb in the EU and Class II in the US made by Plasmapp Co., Ltd., registered in EUDAMED on 9 Jun 2023 (Basic UDI-DI 88000665PLASTPEU8Y) and cleared under FDA 510(k) K231169 on 25 May 2023, active as of 25 Oct 2026.

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K231169↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000665PLASTPEU8Y Basic UDI-DI 08800066500290UDI-DIDate9 Jun 2023RegisteredStatusActive EUDAMED: not on the EU market
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Special NumberK231169 Date25 May 2023ClearedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000665PLASTPEU8Y registered 9 Jun 2023 Active
  • FDA 510(k) K231169 decided 25 May 2023 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K231169
  2. Registered EUDAMED 88000665PLASTPEU8Y

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Specification

EUDAMED · 510(k)

Full name
STERLINK plus
Model / reference
FPS-15s Plus, STERLINK
Primary DI / UDI-DI
08800066500290
Basic UDI-DI
88000665PLASTPEU8Y
510(k) Number
FDA product code
MLR
EMDN code
S900199 Devices for gas plasma sterilisation (excluding cat. d - z) - other
Device class
Class IIb EUDAMED
Class II 510(k)
Regulation
21 CFR Part 880.6860
System or procedure pack
System which is a device in itself
EU registration type
Standard device
Advisory committee
General Hospital
FDA decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device classEUDAMED
Class IIb
510(k)
Class II

Device class is stated on each registry's own scale: Class IIb in the EU (EUDAMED), Class II in the US (FDA 510(k)). EU and US classes are different schemes, so this is not a disagreement.

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Source: 510k-lineage (choiben314), CC BY 4.0

Manufacturer details

EUDAMED SRN
KR-MF-000012193
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Similar devices in this category

Other devices filed under DEVICES FOR GAS PLASMA STERILISATION (EXCLUDING CAT. D - Z) - OTHER.

Other devices from Plasmapp Co., Ltd.

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See all devices from Plasmapp Co., Ltd. →

Properties

Other properties (14, all answered No)