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Mermaid Medical A/S

DenmarkFDA applicant, unverified FDA FEI 3007146453

Devices
261
Registrations
FDA
FDA recalls
21 ongoing

Catalogue261

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Company details

FDA FEI number
3007146453
Address
Frydensbergvej 25, Stenloese Hovedstaden
Email
[email protected](from company website)
Phone
+45 47 10 85 70(from company website)

FDA recalls2

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

Recalls initiated per year

  • 2017 0
  • 2018 0
  • 2019 0
  • 2020 0
  • 2021 0
  • 2022 0
  • 2023 0
  • 2024 1
  • 2025 0
  • 2026 0

1 initiated before 2017

  • 2024

    • 1 May 2024 Z-2213-2024 Class II Ongoing Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact. Distribution: Worldwide - US Nationwide distribution in the states of OH, MO, CO, NC, TX, MA, GA, FL, IL, IN, MD, PA, VA, and the…
      Full distribution text Worldwide - US Nationwide distribution in the states of OH, MO, CO, NC, TX, MA, GA, FL, IL, IN, MD, PA, VA, and the country of Chile.
      Submission number: K021641

  • 2015

    • 15 Jun 2015 Z-2190-2015 Class II Terminated Mermaid Medical A/S is recalling some of their M-Biopsy Coaxial Introducer Needles because of the potential for small plastic pieces to be present in the luer of the cannula. Distribution: US Distribution to FL including PR.

From the company website

Read 18 Sep 2026

At Mermaid Medical, we want to help save and improve patient lives by engaging in trustworthy partnerships with healthcare professionals. We pursue this through continuous development and global distribution of secure and effective interventional products.

From the manufacturer's own website. Source