Data / Medical devices / Czechia / Medicem Technology s.r.o
Medicem Technology s.r.o: FDA-registered device maker in Kamenne Zehrovice Stredocesky Kraj, Czechia, 1 510(k) clearance
Medicem Technology s.r.o is registered with the FDA (registration 3003994796) in Kamenne Zehrovice Stredocesky Kraj, Czechia. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated April 17, 2015. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003994796
- FEI number
- 1000573518
- Address
- Karlovarska trida 20, Kamenne Zehrovice Stredocesky Kraj, Czechia, 273 01
- Owner or operator
- MEDICEM Technology (9041858)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- April 29, 2015
- Registered through
- 2026
- Brand names listed
- Dilapan-S
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Dilator, Cervical, Synthetic, Osmotic | PKN | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| April 17, 2015 | K143447 | Dilapan-S | PKN | Substantially Equivalent | Medicem Technology S.R.O | accessdata.fda.gov |
Updated April 17, 2015. 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.