HomeSwedenSECTRA AB

SECTRA AB

Sweden · Linkoping
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Singapore, Australia, Israel, Russia — 6 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
3listed device types
Class I 1Class II 2Class III 0
plus 4 registration records and 5 510(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
4active device licences
Class II 4
7 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
2device registrations
CLASS B 2
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class I 1IVD Class 2 1IIb 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
1active registrations
Class 2b 1
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 States4 registration records, 5 510(k), 0 PMA, 2 excluded
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: SECTRA AB

Company information

Country
Sweden
City
Linkoping

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

12000 · K001140
12003 · K033088
12004 · K034059
12020 · K193054
12024 · K232208

FDA listed device types

System, Image Processing, Radiological 1Digital Pathology Image Viewing And Management Software 1Instrument, Quality-Assurance, Radiologic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK232208Sectra Digital Pathology Module (Version 3.3)2024-04-16
USK193054Sectra Digital Pathology Module2020-03-31
USK034059SECTRA ANGIOGRAPHY PACKAGE AND SECTRA CARDIOLOGY PACKAGE2004-03-09
CA77050SECTRA ORTHOPEDIC PACKAGEClass II
CA77051SECTRA PACS COREClass II
CA77052SECTRA WORKSTATIONClass II

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