Philippines FDA registration MDR-05948

CONFIDA™ BRECKER GUIDEWIRE

Philippines·Medtronic International Limited. - Singapore Mfd. by: EPflex Feinwerktechnik GmbH – Im Schwöllbogen 24 72581 Dettingen/Erms Germany For Medtronic CoreValve LLC - 1851 E. Deere Avenue, Santa Ana, CA, 92705, USA·USA·Issued June 17, 2025 – August 10, 2028

Device information

Product Name: CONFIDA™ BRECKER GUIDEWIRE
Registration Number: MDR-05948

Manufacturer details

Manufacturer: Medtronic International Limited. - Singapore Mfd. by: EPflex Feinwerktechnik GmbH – Im Schwöllbogen 24 72581 Dettingen/Erms Germany For Medtronic CoreValve LLC - 1851 E. Deere Avenue, Santa Ana, CA, 92705, USA
Country of Origin: USA

Importer & distribution

Importer/Distributor: Medtronic Philippines, Inc

Registration dates

Issuance Date: June 17, 2025
Expiry Date: August 10, 2028

About this record

Access comprehensive regulatory information for CONFIDA™ BRECKER GUIDEWIRE in the Philippines medical device market through Pure Global AI's free database. This device is registered under FDA registration number MDR-05948 and manufactured by Medtronic International Limited. - Singapore Mfd. by: EPflex Feinwerktechnik GmbH – Im Schwöllbogen 24 72581 Dettingen/Erms Germany For Medtronic CoreValve LLC - 1851 E. Deere Avenue, Santa Ana, CA, 92705, USA in USA. The device was registered on June 17, 2025.

This page provides complete registration details including manufacturer information, importer/distributor details (Medtronic Philippines, Inc), and regulatory compliance data from the official Philippines FDA medical device database. Pure Global AI offers free access to Philippines' complete medical device registry, helping global MedTech companies navigate FDA regulations efficiently.