Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030450856

FEI Number

3030450856

Entity Name

CALYX MEDICAL Sp. Z.O.O.

City/State/Country

Wroclaw Dolnoslaskie, PL

Establishment Address

53-338 Wroclaw, ul. Wielka 31/2, Wroclaw Dolnoslaskie 53-338, PL

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Wismed PL Sp. z o.o. (Owner Number: 10089892)

Owner / Operator Contact Address

53-338 Wroclaw, ul. Wielka 31/2, Wroclaw, PL-02 53-338, PL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Sealing Connector Y-Piece Sealing Connector Straight Body Sealing Connector T-Piece Another Hand Dual Action Pump

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EYK	Connector, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2025-02-20
EYJ	Holder, Ureteral Catheter	Gastroenterology, Urology	Class 1	876.5130	2025-02-20
FFD	Evacuator, Bladder, Manually Operated	Gastroenterology, Urology	Class 1	876.4370	2025-02-20

Official Correspondent

Kira Wisniewski

US Agent Details

Alex Ebner Business: ACE Medical Company Email: alex@acemedicalco.com Phone: (800) 8220314

Related Public Records

Same Entity

Wismed PL Sp. z o.o.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030450856. Last updated year: 2026. Please use registration number 3030450856 when referencing this establishment in official correspondence.