Altis Single Incision Sling System
Coloplast A/S
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3011307048 | 3011307048 | Coloplast A/S - Mordrup Site | 1 | N | 2026-01-01 | Aa. Louis-Hansens Alle 15 Espergaerde Hovedstaden DK 3060 |
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 05701780456500 | SenSura Mio Convex Flip - 184030 | +1(800)533-0464 | healthcarecs@coloplast.com |
| 05701780456838 | SenSura Mio Convex Flip - 184040 | +1(800)533-0464 | healthcarecs@coloplast.com |
| 05701780457330 | SenSura Mio Convex Flip - 184050 | +1(800)533-0464 | healthcarecs@coloplast.com |
| 05701780459556 | SenSura Mio - 105860 | +1(800)533-0464 | healthcarecs@coloplast.com |
| 05701780459587 | SenSura Mio - 122980 | +1(800)533-0464 | healthcarecs@coloplast.com |
| 05701780459617 | SenSura Mio Convex - 137340 | +1(800)533-0464 | healthcarecs@coloplast.com |
| 05701780459730 | SenSura Mio Convex - 168100 | +1(800)533-0464 | healthcarecs@coloplast.com |
| 05708932135184 | Conveen - 05050 | +1(800)533-0464 | healthcarecs@coloplast.com |
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 175949 | 1857604852 | K180258 | SpeediCath Standard | GBM | 2018-10-25 |
| 175949 | 1836703167 | K143182 | Speedicath Compact Male | GBM | 2015-01-20 |
| 175949 | 1498251775 | K121458 | SPEEDICATH COMPACT SET (12/18 FR) | GBM | 2012-10-01 |
| 175949 | 1923071866 | K023254 | SPEEDICATH | GBM | 2003-01-27 |
| 175949 | 1398980614 | ||||
| 175949 | 1471863104 | ||||
| 175949 | 1554983951 |
| Product code | Registration listing records | Latest decision |
|---|---|---|
| GBM | 4 | 2018-10-25 |
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