Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3003994796

FEI Number

1000573518

Entity Name

Medicem Technology s.r.o

City/State/Country

Kamenne Zehrovice Stredocesky Kraj, CZ

Establishment Address

Karlovarska trida 20, Kamenne Zehrovice Stredocesky Kraj 273 01, CZ

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Manufacture Medical Device

Owner / Operator

MEDICEM Technology (Owner Number: 9041858)

Owner / Operator Contact Address

KARLOVARSKA TRIDA 20, --, KAMENNE ZEHROVICE, CZ-20 273 01, CZ

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K143447

PMA Number

N/A

All Registered Proprietary Names

Dilapan-S

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PKN	Dilator, Cervical, Synthetic, Osmotic	Obstetrics/Gynecology	Class 2	884.4260	2015-04-29

Official Correspondent

Jana Subrtova

US Agent Details

Susanne Parks Business: Medicem Inc. Email: USRegulatory@medicem.com Phone: (862) 2680960

Related Public Records

Same Entity

MEDICEM Technology

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Similar Registrations

Registration Number	Establishment Name	Location
3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN
3038274470	BRAINMATTERZ, INC	McKinney, TX, US
3012404174	LABORATORIO CHIMICO FARMACEUTICO A. SELLA SRL.	Schio Vicenza, IT
3042364673	NEURALYTIX LLC	Fruita, CO, US
3043617526	AD SCIENTIAM	Paris Ile-de-France, FR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3003994796. Last updated year: 2026. Please use registration number 3003994796 when referencing this establishment in official correspondence.