Mermaid Medical A/S
DenmarkFDA applicant, unverified FDA FEI 3007146453
- Devices
- 261
- Registrations
- FDA
- FDA recalls
- 21 ongoing
At a glance
Market reach
- United States
- FDA FEI, FDA recalls
Catalogue
Search and filter all 261 devicesShowing 1-50 of 261
Company details
- FDA FEI number
- 3007146453
- Address
- Frydensbergvej 25, Stenloese Hovedstaden
- Website
- www.mermaidmedical.com
- [email protected]
- Phone
- +45 47 10 85 70
FDA recalls
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 1
- 2025 0
- 2026 0
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.
Full distribution text
- 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.
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.
From the company website
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.
Frequently asked questions
How many devices does Mermaid Medical A/S have in the registry?
The registry currently lists 261 devices for Mermaid Medical A/S. Devices recorded under merged duplicate company entries are counted once.
Which registries list Mermaid Medical A/S's devices?
Among its 50 most recently registered devices, Mermaid Medical A/S has devices listed in FDA GUDID (50 devices).
What risk classes do Mermaid Medical A/S's devices fall under?
Among its 50 most recently registered devices, the classes recorded for Mermaid Medical A/S's devices are Class I and Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Mermaid Medical A/S?
FDA recall records list 2 recalls initiated by Mermaid Medical A/S, the most recent initiated on 1 May 2024. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Mermaid Medical A/S in the registry?
The most recently registered devices listed for Mermaid Medical A/S include M-Drain D11012030S, M-Drain D11014030S, Drain-Lok A30100512 and Drain-Lok A30101218.