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Sereine Wetting & Soaking Solution

by Trp Company PMA

Active European Union and United States

PMA P870051

Overview

Sereine Wetting & Soaking Solution is an accessory for soft lens products used to wet and soak contact lenses. It is designed to maintain lens hydration and cleanliness during storage and before insertion.

The solution is supplied as a sterile product and is intended for single-use application. It is regulated under FDA PMA and MDR authorizations with product code LPN and is manufactured by Trp Company in Reno, NV.

AI-generated from registry data, 18 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMAAPPR Approved 1 supplement NumberP870051 Date6 Dec 1990ApprovedStatusActive
European UnionCE/MDR Number— Date—StatusNot known

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Not known
  • United States FDA PMA Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 6 Oct 2026.

Specification

PMA

Generic Name
Accessories, soft lens products
PMA Number
FDA Product Code
LPN
Device Class
Class II
Regulation
21 CFR Part 886.5928
Advisory Committee
Ophthalmic
FDA Decision
APPR Approved
PMA Supplement
S001 (Normal 180 Day Track)

Other devices from Trp Company

Questions

  • What is the purpose of Sereine Wetting & Soaking Solution?

    Sereine Wetting & Soaking Solution is an accessory for soft lens products used to wet and soak contact lenses. It maintains lens hydration and cleanliness during storage and before insertion.

  • How is Sereine Wetting & Soaking Solution supplied?

    The solution is supplied as a sterile product and is intended for single-use application. It is manufactured by Trp Company in Reno, NV.

  • What are the regulatory authorizations for Sereine Wetting & Soaking Solution?

    Sereine Wetting & Soaking Solution is regulated under FDA PMA and MDR authorizations with product code LPN. It is classified as a Class II medical device for ophthalmic use.

  • Can Sereine Wetting & Soaking Solution be reused?

    No, Sereine Wetting & Soaking Solution is intended for single-use application only and should not be reused to ensure proper hygiene and effectiveness.