Sterlink Plus FPS-15s Plus
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Identity
- Trade Name
- STERLINK plus EUDAMED
- Model / Reference
- FPS-15s Plus EUDAMEDSTERLINK EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800066500290 EUDAMED
- Basic UDI-DI
- 88000665PLASTPEU8Y EUDAMED
- 510(k) Number
- K231169 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 EUDAMEDClass 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
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
The Sterlink Plus FPS-15s Plus is a low‑temperature plasma sterilizer classified as Class IIb (NOMENCLATURE_CODE S900199). It uses active plasma technology to achieve rapid sterilization cycles for delicate and high‑value medical items without heat, and the device itself is non‑sterile and not intended for implantation or reuse.
The tabletop unit includes a built‑in pump and an internal chamber measuring 10.4 × 16.1 × 4.9 inches (approximately 3.7 gallons). It is supplied as a non‑sterile, single‑use system and is authorized under FDA 510(k), MDD and MDR. The device is identified by UDI 88000665PLASTPEU8Y and model code FPS-15s Plus.
Frequently asked questions
What is the Sterlink Plus FPS-15s Plus used for?
This device is a low-temperature plasma sterilizer designed to achieve rapid sterilization cycles for delicate and high-value medical items without using heat.
Is the Sterlink Plus FPS-15s Plus sterile or reusable?
The device itself is non-sterile and is intended for single-use only. It is not designed for reuse or implantation.
What are the dimensions of the Sterlink Plus FPS-15s Plus?
The tabletop unit has an internal chamber measuring 10.4 x 16.1 x 4.9 inches, which is approximately 3.7 gallons.
How is the Sterlink Plus FPS-15s Plus supplied?
It is supplied as a non-sterile, single-use system.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: STERLINK Plus | Plasmapp, Sterlink Plus Sterilizer - Plasmapp America, PDF STERLINK Plus STERLINK mini - Medical Parts and Supplies, LLC
Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDD
FDA_510K
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | 88000665PLASTPEU8Y | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K231169 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | 88000665PLASTPEU8Y | Class IIb | Active |
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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 a64cd858-1f5f-42fd-801c-ba99983be7f8 61 fields · synced Sep 21, 2026
- FDA 510(k) K231169 24 fields · synced May 18, 2026