Facility

MERMAID MEDICAL A/S

2 recall(s) on record — most severe on record: Class II.

Key facts

2recalls · worst Class II

1inspections · worst NAI

—warning letters in our data

Recalls are listed for the parent company: openFDA recall records do not name a facility. How we attribute records

FDA Establishment Identifier (FEI)	3007146453
Establishment type	Repack or Relabel Medical Device; Manufacture Medical Device
Location	Frydensbergvej 25 Stenloese Hovedstaden, DK DK-3660
Registration status	Active · expires 2026
Parent company	Mermaid Medical (owner-operator 10045264)
Brand names	M- Drain Catheter

Activity by year

Recalls (2)
Inspections (1)

Devices registered here (3)

Catheter, Nephrostomy, General & Plastic Surgery
Product code GBO (opens in a new tab) · Class I · General, Plastic Surgery · 21 CFR 878.4200
Catheter, Nephrostomy
Product code LJE (opens in a new tab) · Unclassified · Unknown
Stents, Drains And Dilators For The Biliary Ducts
Product code FGE (opens in a new tab) · Class II · Gastroenterology, Urology · 21 CFR 876.5010

Recalls & enforcement

Class IIOngoing2024-05-01
Internal product testing failed bubble leak testing (ASTM F2096), which indicates the sterility barrier may not be fully intact.
Class IITerminated2015-06-15
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.

FDA inspections (1)

NAI2017-05-04
No Action Indicated · Compliance: Devices; Postmarket Assurance: Devices

Source: U.S. FDA Inspections Dashboard (opens in a new tab) (device inspection classifications, 2016–present). Data as of 2026-10-06. The dashboard profile can take several seconds to load.

Source: U.S. FDA via openFDA (opens in a new tab) (device registration & enforcement). Data as of 2026-10-06. Verify this facility record at FDA → (opens in a new tab)

Cite this record

RegWarden. “MERMAID MEDICAL A/S (FEI 3007146453) — FDA facility record.” Compiled from U.S. FDA public records (openFDA; FDA Data Dashboard). Data as of 2026-10-06. https://regwarden.com/facility/3007146453-mermaid-medical-a-s/

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