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Home›Slovenia›Tosama, D.O.O.

Tosama, D.O.O.

Slovenia · Domzale
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, Canada — 3 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 1Class II 1Class III 0
plus 3 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
1registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
6active device licences
Class II 6
10 including historic records
TWTaiwanTFDA
0valid device licences
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 States3 registration records, 5 510(k), 0 PMA, 1 excluded
Saudi Arabia1 confirmed, 0 excluded
Canada6 confirmed, 0 excluded
Manufacturer names merged into this page: TOSAMA d.o.o. · TOSAMA D.O.O. · Tosama d.o.o

Company information

Country
Slovenia
City
Domzale

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

12012 · K120481
22015 · K151170
12018 · K172504
12024 · K232060

FDA listed device types

Tampon, Menstrual, Unscented 1Pad, Menstrual, Unscented 1

Registration details (sample)

MarketIdentifierNameClass / date
USK232060TOSAMA Reusable Applicator2024-04-12
USK172504Tosama Biobased Applicator Tube Menstrual Tampon2018-02-09
USK151170Tosama 100% Organic Cotton Menstrual Tampon2015-07-02
SAME0000022842SFDAA00001Organ(y)c biobased compact applicator tampons (Regular + Super + Super—
CA88018MOXIE TAMPONSClass II
CA89413MENSTRUAL TAMPONSClass II
CA101784MENSTRUAL TAMPONS WITHOUT APPLICATORClass II

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