HomeSwedenBIO-HOSPITAL AB

BIO-HOSPITAL AB

Sweden · Kopparberg Orebro
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Taiwan — 2 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 2 registration records and 0 510(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
0active device licences
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
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 States2 registration records, 0 510(k), 0 PMA, 82 excluded
Brazil0 confirmed, 15 excluded
Saudi Arabia0 confirmed, 7 excluded
Canada0 confirmed, 8 excluded
Manufacturer names merged into this page: BIO-HOSPITAL AB

Company information

Country
Sweden
City
Kopparberg Orebro

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 listed device types

Prosthesis, Knee, Patello/Femoral, Semi-Constrained, Cemented, Metal/Polymer 1Agent, Bulking, Injectable For Gastro-Urology Use 1

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 →