HomeSwedenQ-MED AB

Q-MED AB

Sweden · Uppsala
✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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
5listed device types
Class I 0Class II 1Class III 4
plus 7 registration records and 0 510(k), 251 PMA
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
9 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
2active device licences
Class III 2
11 including historic records
TWTaiwanTFDA
4valid device licences
Class III 4
SGSingaporeHSA SMDR
13device registrations
CLASS B 1CLASS D 4D WITH MEDICINAL PRODUCT 8
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
9active ARTG entries
Class III 9
HKHong KongMDACS
11valid listings
Class IV 11
ILIsraelAMAR
5registrations
RURussiaRoszdravnadzor
5active registrations
Class 2a 1Class 3 4
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 States7 registration records, 0 510(k), 251 PMA, 343 excluded
Brazil1 confirmed, 132 excluded
Saudi Arabia0 confirmed, 34 excluded
Canada2 confirmed, 48 excluded
Manufacturer names merged into this page: Q-MED AB

Company information

Country
Sweden
City
Uppsala

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

Agent, Bulking, Injectable For Gastro-Urology Use 1Implant, Dermal, For Aesthetic Use 1Implant, Dermal, For Aesthetic Use In The Hands 1Acid, Hyaluronic, Intraarticular 1Hydrogel Spacer 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80794390025Cânula Deflux®Class II
CA63470ZUIDEXClass III
CA68681RESTYLANE SUBQClass III

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