HomeSwedenABIGO MEDICAL AB

ABIGO MEDICAL AB

Sweden · Askersund
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong — 8 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
1listed device types
Class I 0Class II 0Class III 0unclassified 1
plus 9 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
5 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
11 including historic records
TWTaiwanTFDA
3valid device licences
Class II 3
SGSingaporeHSA SMDR
7device registrations
CLASS C 7
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
3active ARTG entries
Class I 1IIb 2
HKHong KongMDACS
2valid listings
Class III 2
ILIsraelAMAR
pendingnot queried
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 States9 registration records, 5 510(k), 0 PMA
Manufacturer names merged into this page: ABIGO MEDICAL AB

Company information

Country
Sweden
City
Askersund

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

11992 · K920840
12007 · K063059
12011 · K100591
12016 · K153674
12017 · K171225

FDA listed device types

Dressing, Wound, Drug 1

Registration details (sample)

MarketIdentifierNameClass / date
USK171225Sorbact Wound Dressing-Ribbon Gauze2017-08-21
USK153674Sorbact Foam Gentle Border, Sorbact Superabsorbent2016-07-01
USK100591SORBACT2011-01-24

Similar companies

Aerte AB
Sweden · markets 0
Alfapac AB
Sweden · markets 0
AMB Industri AB
Sweden · markets 1
Backer AB/Div. Calesco
Sweden · markets 0
Beneli AB
Sweden · markets 1
Billerud AB
Sweden · markets 0
Is this your company? Claim the page, add information or report a data error.Claim / report an error →