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Remeex System - Thread Passer AR-03

by Desarrollo E Investigacion Medica Aragonesa Sl

Remeex System - Thread Passer AR-03 is a Class II device made by Desarrollo E Investigacion Medica Aragonesa Sl, listed in FDA GUDID since 19 Oct 2020 (UDI-DI 08437007606263), registry data as of 23 Oct 2026.

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None

No authorization documents

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08437007606263 UDI-DI Date19 Oct 2020ListedStatusListed GUDID: in commercial distribution

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade name
Remeex System - Thread Passer
Generic name
Transvaginal mesh-sling introduction needle
Model / reference
AR-03
Primary DI / UDI-DI
08437007606263
FDA product code
OTN
GMDN term
Transvaginal mesh-sling introduction needle
Device class
Class II
Regulation number
878.3300
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices

Other devices filed under FDA product code OTN (Mesh, Surgical, Synthetic, Urogynecologic, For Stress Urinary Incontinence, Retropubic Or Transobturator).

Other devices from Desarrollo E Investigacion Medica Aragonesa Sl

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Properties

  • Sterilise before use
  • Lot / batch number
  • Serial number
Other properties (12, all answered No)