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Home›Denmark›MERMAID MEDICAL A/S

MERMAID MEDICAL A/S

Denmark · Stenloese
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable
CNChinaNMPA
n/aThis registry lists domestic registrants only
EUEuropean UnionEUDAMED
pendingnot queried
USUnited StatesFDA openFDA
8listed device types
Class I 2Class II 5Class III 0unclassified 1
plus 11 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
3active device licences
Class II 3
7 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
pendingnot queried
Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States11 registration records, 1 510(k), 0 PMA, 1 excluded
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: MERMAID MEDICAL A/S · Mermaid Medical A/S (FL Site)
Same-named companies — This database also contains companies with near-identical names: Mermaid Medical A/S (FL Site). Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Denmark
City
Stenloese

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

12016 · K161409

FDA listed device types

Instrument, Biopsy 1Wire, Guide, Catheter 1Dilator, Vessel, For Percutaneous Catheterization 1Stents, Drains And Dilators For The Biliary Ducts 1Short-Term Intravascular Filter Catheter 1Catheter, Nephrostomy, General & Plastic Surgery 1Needle, Biopsy, Cardiovascular 1Catheter, Nephrostomy 1

Registration details (sample)

MarketIdentifierNameClass / date
USK161409M-Biopsy Semi-Automatic Biopsy Instrument M-Biopsy Coaxial Introducer Needle for Sem2016-08-02
CA99987M-DRAIN CENTESIS CATHETERClass II
CA100203M-BIOPSY SEMI AUTOMATIC BIOPSY INSTRUMENTSClass II
CA107595D*CLOT HD ROTATIONAL THROMBECTOMY SYSTEMClass II

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