International safety notice
Technical name: Female Contraceptive Devices
Brazil / Anvisa · BRA · Feb 23, 2017
Key facts
| Title | Technical name: Female Contraceptive Devices |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Trade name: ESSURE SYSTEM Technical name: Devices for Female Contraception ANVISA registration number: 80274190001 Risk class: IV Maximum Risk Affected models: ESS305 Affected batch numbers: All batches ### UPDATE ON 11/29/2018: FROM 12/24/2018 THE TRANSFER OF OWNERSHIP OF THE PRODUCT REGISTRATION TO THE COMPANY BAYER S.A. - CNPJ 18.459.628/0001-15. |
| Manufacturer | EMPRESA DETENTORA DO REGISTRO COMERCIAL COMMED PRODUTOS HOSPITALARES LTDA INSCRITA NO CNPJ SOB O NÚMERO 02643718000121 SITA A RUA BORGES LAGOA 1220 VILA MARIANA SÃO PAULO SP PESSOA PARA CONTATO AUGUSTO NEVES FONE 11 50818282 AUGUSTONEVESCOMMEDCOMBR FABRICANTE BAYER HEALTH CARE LLCI ESTADOS UNIDOS DA AMÉRICA 1011 MCCARTHY BLVD MILPITAS CALIFÓRNIA 95035 |
| Models | 0001-15, 18.459.628, 80274190001, ESS305, 80384380061 |
| Date | Feb 23, 2017 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1