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Sterlink

by Plasmapp Co., Ltd

Ref STERLINKModel STERLINK mini, FPS-15s Plus510(k) K223015

Sterlink 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 4 Apr 2025 (Basic UDI-DI B-08800066500283) and cleared under FDA 510(k) K223015 on 9 May 2023, active as of 23 Oct 2026.

Active European Union and United States

CE MDR CE MDD 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K223015↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberB-08800066500283 Basic UDI-DI Date4 Apr 2025RegisteredStatusActive
European UnionCE/MDD EUDAMED NumberB-08800066500283 Basic UDI-DI Date4 Apr 2025RegisteredStatusActive
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK223015 Date9 May 2023ClearedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08800066500283 registered 4 Apr 2025 Active· +1 more in the status table
  • FDA 510(k) K223015 decided 9 May 2023 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K223015
  2. Registered EUDAMED B-08800066500283

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / reference
STERLINK mini, STERLINK, FPS-15s Plus
Primary DI / UDI-DI
08800066500283, 08800066500276
Basic UDI-DI
B-08800066500283, 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
Legacy device (under a directive)
Standard device
EU market of registration
Germany
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.

  • Sterlink™ BT96

    Class II

  • STERLINK™ Mini-bio

    Class II

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    Class II

  • Sterlink™ CD42

    Class II

See all devices from Plasmapp Co., Ltd. →

Properties

Other properties (14, all answered No)