Data / Medical devices / Croatia / Zamar Medical Doo
Zamar Medical Doo: FDA-registered device maker in Brtonigla Istarska Zupanija, Croatia, 1 510(k) clearance
Zamar Medical Doo is registered with the FDA (registration 3016746289) in Brtonigla Istarska Zupanija, Croatia. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated May 5, 2025. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3016746289
- Address
- Ulica Ronki 1/A, Brtonigla Istarska Zupanija, Croatia, 52466
- Owner or operator
- ZAMAR MEDICAL DOO (10084778)
- Roles
- Manufacturer
- First device listed
- May 4, 2022
- Registered through
- 2027
- Brand names listed
- THERMAL WRAP, Z-ONE (MG455A), ZT Clinic (MG675A), ZT Cube (ZC3) (MG465A)
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Powered Inflatable Tube | IRP | 2 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Reusable | IME | 1 | Manufacturer | accessdata.fda.gov |
| Pack, Hot Or Cold, Water Circulating | ILO | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 5, 2025 | K242754 | ZT Clinic (MG675A); ZT Cube (ZC3) (MG465A); Z-ONE (MG455A) | IRP | Substantially Equivalent | Zamar Medical D.O.O. | accessdata.fda.gov |
Compare with other makers
- All makers of Pack, Hot Or Cold, Water Circulating
- All makers of Massager, Powered Inflatable Tube
- All makers of Pack, Hot Or Cold, Reusable
Updated May 5, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.