Data / Medical devices / Denmark / Mermaid Medical A/S
Mermaid Medical A/S: FDA-registered device maker in Stenloese Hovedstaden, Denmark, 4 510(k) clearances
Mermaid Medical A/S is registered with the FDA (registration 3007146453) in Stenloese Hovedstaden, Denmark. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated December 22, 2025. 2 recall events name it as the recalling firm. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3007146453
- Address
- Frydensbergvej 25, Stenloese Hovedstaden, Denmark, DK-3660
- Owner or operator
- Mermaid Medical (10045264)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- November 21, 2013
- Registered through
- 2027
- Brand names listed
- Angel® Catheter, Angel® Catheter Accesory Kit, Angel® Catheter Accessory Kit, M- Drain Catheter, M-Biopsy, M-Drain Percutaneous Introducer System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Catheter, Nephrostomy | LJE | U | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Catheter, Nephrostomy, General & Plastic Surgery | GBO | 1 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Dilator, Vessel, For Percutaneous Catheterization | DRE | 2 | Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Needle, Biopsy, Cardiovascular | DWO | 1 | Exporter to the US, Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Short-Term Intravascular Filter Catheter | PNS | 2 | Manufacturer | accessdata.fda.gov |
| Stents, Drains And Dilators For The Biliary Ducts | FGE | 2 | Manufacturer, Repackager or relabeler | accessdata.fda.gov |
| Wire, Guide, Catheter | DQX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 22, 2025 | K251019 | BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-G | FGE | Substantially Equivalent | Bioteque Corporation | accessdata.fda.gov |
| July 28, 2016 | K160747 | Angel Catheter | PNS | Substantially Equivalent | Bio2 Medical, Inc. | accessdata.fda.gov |
| October 31, 2007 | K071330 | GALTSTICK INTRODUCER SYSTEM | DRE | Substantially Equivalent | Galt Medical Corp. | accessdata.fda.gov |
| March 31, 1994 | K935170 | CARDIOVASCULAR AND VASCULAR GUIDEWIRE MODIFICATIONS | DQX | Substantially Equivalent | Lake Region Mfg., Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| May 1, 2024 | 94741 | Class II | Ongoing | The D*Clot HD Rotational Thrombectomy System is a percutaneous catheter-based system available in 6 French. The disposable system consists of an outer sheath through which a rotatable radiopaque spiral shaft extends endi | Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact. | accessdata.fda.gov |
| June 15, 2015 | 71525 | Class II | Terminated | Mermaid Medical M-Biopsy Coaxial Introducer Needle, Coaxial Needle for M-Biopsy 18Gx10cm-PRO-MAG, RX Only. Single packed device in a tyvek pouches. 10 single packed devices in a white carton unit box. The M-Biopsy coaxia | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Wire, Guide, Catheter
- All makers of Needle, Biopsy, Cardiovascular
- All makers of Dilator, Vessel, For Percutaneous Catheterization
- All makers of Catheter, Nephrostomy, General & Plastic Surgery
- All makers of Catheter, Nephrostomy
- All makers of Stents, Drains And Dilators For The Biliary Ducts
Updated December 22, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.