HomeDenmarkFERROSAN MEDICAL DEVICES A/S

FERROSAN MEDICAL DEVICES A/S

Denmark · Soeborg
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Hong Kong, Israel, Russia — 9 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
2listed device types
Class I 0Class II 1Class III 1
plus 3 registration records and 1 510(k), 79 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
3 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
3 including historic records
TWTaiwanTFDA
3valid device licences
Class III 3
SGSingaporeHSA SMDR
3device registrations
CLASS D 2D WITH MEDICINAL PRODUCT 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class III 5
HKHong KongMDACS
3valid listings
Class IV 3
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
3active registrations
Class 3 3
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 States3 registration records, 1 510(k), 79 PMA
Manufacturer names merged into this page: Ferrosan Medical Devices Sp. z o.o. · FERROSAN MEDICAL DEVICES A/S · FERROSAN MEDICAL DEVICES SP. Z.O.O.

Company information

Country
Denmark
City
Soeborg

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

12017 · K171193

FDA listed device types

Agent, Absorbable Hemostatic, Collagen Based 1Instrument, Biopsy 1

Registration details (sample)

MarketIdentifierNameClass / date
USK171193Certa Catheter2017-12-18

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