TOSAMA d.o.o.

FDA Device Registration & Listing · Domzale, SI · Registration 3007740671

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3007740671
FEI Number
3007740671
Entity Name
TOSAMA d.o.o.
City/State/Country
Domzale, SI
Establishment Address
Vir, Saranoviceva Cesta 35, Domzale 1230, SI
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
TOSAMA d.o.o. (Owner Number: 10029863)
Owner / Operator Contact Address
Saranoviceva 35, Vir, Domzale, SI-023 1230, SI
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K150897
PMA Number
N/A

All Registered Proprietary Names

External pads, various brands and models Tosama 100% Cotton Menstrual Tampon

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
HHD Pad, Menstrual, Unscented Obstetrics/Gynecology Class 1 884.5435 2019-08-19
HEB Tampon, Menstrual, Unscented Obstetrics/Gynecology Class 2 884.5470 2015-05-04

Official Correspondent

No official correspondent registered.

US Agent Details

Christopher J. Graham Email: grahamrts@gmail.com Phone: (570) 6605892

Related Public Records

Same Entity

TOSAMA d.o.o.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K823241 Kimberly-Clark Corp. NEW FREEDOM THIN UNSCENTED MAXI PADS 1982-12-28
K923985 Personal Products Co. UNSCENTED MENSTRUAL TAMPON 1993-02-19
K151170 Tosama, D.O.O. Tosama 100% Organic Cotton Menstrual Tampon 2015-07-02
K930149 Kimberly-Clark Corp. KOTEX DISCRETE DIGITAL TAMPONS, REG.,SUPER,SUPER+ 1994-03-02

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3007740671. Last updated year: 2026. Please use registration number 3007740671 when referencing this establishment in official correspondence.
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