International safety notice
Devices for female contraception
Brazil / Anvisa · BRA · Apr 12, 2016
Key facts
| Title | Devices for female contraception |
|---|---|
| Regulator | Brazil / Anvisa |
| Country | BRA |
| Brand | Commercial name of the product: ESSURE SYSTEM /// Registration number: 80274190001/// model: ESS305/// Batches: ALL LOTS/// Product risk class: IV (Maximum Risk). ### 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 | DETENTOR DO REGISTRO COMERCIAL COMMED PRODUTOS HOSPITALARES LTDA CNPJ 02643718000121 ENDEREÇO R BORGES LAGOA 1170 VILA CLEMENTINO CEP 04038001 SÃO PAULO SP TELEFONE 11 50818282 FABRICANTE BAYER HEALTH CARE LLC ENDEREÇO 1011 MCCARTHY BLVD MILPITAS CALIFÓRNIA EUA TEL 1 862 404 5812 EMAIL DECLANMCGUINNESSBAYERCOM |
| Models | 0001-15, ESS305, 80274190001, 80384380061, 18.459.628 |
| Date | Apr 12, 2016 |
| Regulator page | anvisa.gov.br |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
- 1–9 Matching catalog numbers 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