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Mediphacos Industrias Médicas S/A

Brazil BR-MF-000015743 Last updated 17 Sep 2026

Devices
381
Registries
EUDAMED
FDA recalls
0

Catalogue381

Page 1 of 8

  • Keraring Ref AS6160M20-35C

    Class IIb EUDAMED Active

  • Keraring Ref SI6A155M300

    Class IIb EUDAMED Active

  • Keraring Ref SGA330D35M360

    Class IIb EUDAMED Active

  • Keraring Ref SGA330D48M390

    Class IIb EUDAMED Active

  • Keraring Ref AS6320M152515

    Class IIb EUDAMED Active

  • Keraring Ref AS5120M15-30W

    Class IIb EUDAMED Active

  • Keraring Ref SI6A140M350

    Class IIb EUDAMED Active

  • Keraring Ref SI6A60M150

    Class IIb EUDAMED Active

  • Keraring Ref SI5A120M350

    Class IIb EUDAMED Active

  • Keraring Ref AS5320M253525

    Class IIb EUDAMED Active

  • Keraring Surgical Instruments Ref OOF174

    Class I EUDAMED Active

  • Keraring Ref SGA160D46M330

    Class IIb EUDAMED Active

  • Keraring Ref SGA210D30M270

    Class IIb EUDAMED Active

  • Keraring Ref SI6A60M300

    Class IIb EUDAMED Active

  • Keraring Ref AS5330M153015

    Class IIb EUDAMED Active

  • Keraring Ref SGA180D40M240

    Class IIb EUDAMED Active

  • Keraring Surgical Instruments Ref OM14.02

    Class I EUDAMED Active

  • Keraring Ref SI6A90M350

    Class IIb EUDAMED Active

  • Keraring Ref SGA180D30M330

    Class IIb EUDAMED Active

  • Keraring Ref AS6180M10-25MT

    Class IIb EUDAMED Active

  • Keraring Ref SI5A320M200

    Class IIb EUDAMED Active

  • Keraring Ref AS5140M25-40C

    Class IIb EUDAMED Active

  • Keraring Ref AS6120M10-25C

    Class IIb EUDAMED Active

  • Keraring Ref SI6A100M300

    Class IIb EUDAMED Active

  • Keraring Ref SGA210D48M360

    Class IIb EUDAMED Active

  • Keraring Ref SI6A90M300

    Class IIb EUDAMED Active

  • Kit for Keraring Implantation Ref OE035

    Class I EUDAMED Active

  • Keraring Ref AS5150M10-20MT

    Class IIb EUDAMED Active

  • Keraring Ref SGA160D35M150

    Class IIb EUDAMED Active

  • Keraring Ref SGA180D48M360

    Class IIb EUDAMED Active

  • Keraring Ref SI5A320M150

    Class IIb EUDAMED Active

  • Keraring Ref AS6160M15-35C

    Class IIb EUDAMED Active

  • Keraring Ref SI5A90M200

    Class IIb EUDAMED Active

  • Keraring Ref SGA330D42M150

    Class IIb EUDAMED Active

  • Keraring Ref AS6140M25-35C

    Class IIb EUDAMED Active

  • Keraring Ref SGA330D30M390

    Class IIb EUDAMED Active

  • Keraring Ref AS6325M253525

    Class IIb EUDAMED Active

  • Keraring Ref AS5320M153015

    Class IIb EUDAMED Active

  • Keraring Ref SI6A155M100

    Class IIb EUDAMED Active

  • Keraring Ref SGA160D35M330

    Class IIb EUDAMED Active

  • Keraring Ref AS6330M15-30MT

    Class IIb EUDAMED Active

  • Keraring Ref AS5325M253525

    Class IIb EUDAMED Active

  • Keraring Ref AS6160M25-40W

    Class IIb EUDAMED Active

  • Keraring Ref SGA330D40M300

    Class IIb EUDAMED Active

  • Keraring Ref AS6320M202520

    Class IIb EUDAMED Active

  • Keraring Ref SI6A150M250

    Class IIb EUDAMED Active

  • Keraring Ref SI5A180M250

    Class IIb EUDAMED Active

  • Keraring Ref SGA210D44M360

    Class IIb EUDAMED Active

  • Keraring Ref SGA160D40M390

    Class IIb EUDAMED Active

  • Keraring Ref SGA210D48M390

    Class IIb EUDAMED Active

Showing 1-50 of 381

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

DNV Product Assurance AS 2460 1 certificate

  • 10000491237-PA-NoMA-BRA Issued

    Quality management system EU MDR

    Issued
    13 Jan 2025
    Expires
    12 Jan 2030

Related companies

Authorised representatives

Notified bodies

About

All Mediphacos products are created and produced under strict quality assurance system, deployed at all levels of the organization and certified in accordance with ISO 13485-2016, CE Mark (Keraring products), GMP from Korea (Keraring products), and Good Manufacturing and Control Practices (Anvisa).

Translated from the manufacturer's own website. Source

What Mediphacos Industrias Médicas S/A makes

Mediphacos Industrias Médicas S/A manufactures a range of Keraring products, primarily consisting of surgical instruments designed for ophthalmic procedures, including corneal cross-linking and refractive surgeries. These devices are intended for use in precision eye treatments, such as corneal reshaping and strengthening. The portfolio also includes variants of Keraring instruments tailored for specific surgical applications.

The company’s devices are classified under Class I, Class IIa, and Class IIb in the European Union, with relevant products registered in the eudamed database. Mediphacos Industrias Médicas S/A is based in Brazil and adheres to regulatory standards including ISO 13485:2016 and national manufacturing practices such as Anvisa’s Good Manufacturing and Control Practices.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does Mediphacos Industrias Médicas S/A manufacture?

Mediphacos Industrias Médicas S/A specializes in producing surgical instruments under the Keraring brand, primarily designed for ophthalmic procedures. These include devices used in corneal cross-linking and refractive surgeries, such as corneal reshaping and strengthening. The company’s portfolio focuses on precision eye treatments, with multiple variants tailored for specific surgical needs.

Where is Mediphacos Industrias Médicas S/A based?

The company is headquartered in Brazil, where it operates under the regulatory framework of the country’s health authority, Anvisa. This location influences its compliance with local manufacturing standards, including Good Manufacturing and Control Practices, alongside broader international certifications.

Which regulatory registries list Mediphacos Industrias Médicas S/A’s devices?

Mediphacos’s devices are registered in the eudamed database, which is the European Union’s central registry for medical devices. This inclusion reflects compliance with EU regulatory requirements, particularly for devices classified under Class I, Class IIa, and Class IIb.

How are Mediphacos’s devices classified in the European Union?

In the EU, Mediphacos’s devices fall under Class I, Class IIa, and Class IIb classifications. The classification determines regulatory scrutiny and post-market obligations, with higher classes (e.g., IIb) typically requiring more rigorous evidence of safety and performance due to their intended use in precision procedures like corneal treatments.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
Brazil(from SRN)
Address
777, Deputado Cristovam Chiaradia , Belo Horizonte, Brazil
Phone
+55 31 2102 22 45
PRRC contact
Aline Lízia de Freitas
EUDAMED SRN
BR-MF-000015743