Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3015460875

FEI Number

3015460875

Entity Name

CIMPAX A/S

City/State/Country

Slangerup Hovedstaden, DK

Establishment Address

Lille Pilevang 4, Slangerup Hovedstaden 3550, DK

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

CIMPAX A/S (Owner Number: 10061849)

Owner / Operator Contact Address

Lille Pilevang 4, Slangerup, DK-NOTA 3550, DK

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K201129

PMA Number

N/A

All Registered Proprietary Names

C-CAT Anesthesia Catheter

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BSO	Catheter, Conduction, Anesthetic	Anesthesiology	Class 2	868.5120	2019-11-25
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2020-11-26

Official Correspondent

Patrick Busch- Madsen

US Agent Details

Manoj Zacharias Business: Liberty Management Group Ltd. Email: office@libertymanagement.us Phone: (630) 2702921

Related Public Records

Same Entity

CIMPAX A/S

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3044854930	CIMPAX CZ s.r.o.	Vyskov, CZ

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K072702	Stryker Instruments, Instruments Div.	STRYKER ANTIMIC CATHETER	2008-03-19
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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3015972753	STERISERVICE SP. Z O.O.	Czestochowa Slaskie, PL
3010321647	ZHEJIANG RUNQIANG MEDICAL INSTRUMENTS CO.,LTD.	Jiaxing Zhejiang, CN
9680425	Avent S. de R.L. de C.V.	TIJUANA Baja California, MX
1319639	Sterigenics U.S., LLC	Queensbury, NY, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3015460875. Last updated year: 2026. Please use registration number 3015460875 when referencing this establishment in official correspondence.