Who else makes this device?

Name: Stockert Remote Control
Brand: Stockert Remote Control

Cardiovascular › DiagnosticCatheter, Electrode Recording, Or Probe, Electrode Recording

Stockert Remote Control

Catalogue number S7019, listed by Stockert Gmbh, Germany, under Catheter, Electrode Recording, Or Probe, Electrode Recording. 5 manufacturers in China are registered for this product code.

Registry build 21.09.26

5manufacturers in China registered for this device type

1catalogue number

Who Else Makes It

Concentrated in Jiangsu (2), Tianjin (1), Shanghai (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DRF
Manufacturer	City	Province	Registered as	Device types
Jiangyin Sinbon Electronics Co Ltd	Jiangyin	Jiangsu	Contract manufacturer	13
Palconn Technology Co., Ltd.	Shenzhen	Guangdong	Contract manufacturer	2
Steris Sterilization Technologies (Suzhou) Ltd	Suzhou	Jiangsu	Contract manufacturer	44
Tianjin Ethylene Oxide Sterilization Technology Co., Ltd.	Tianjin	Tianjin	Contract manufacturer	4
Shanghai Microport EP Medtech Co., Ltd.	Shanghai	Shanghai	Manufacturer	3

Record

Regulatory record for Stockert Remote Control
Listed by	Stockert Gmbh, Germany
FDA product code	DRF
Device type	Catheter, Electrode Recording, Or Probe, Electrode Recording
Device class	Class 2
Regulation	21 CFR 870.1220
Establishment	Manufacturer
Record published	2014-09-23
Record revised	2026-01-19 (version 6)

Specifications

Specifications
MRI safety	Labeling does not contain MRI Safety Information
Prescription	Prescription only
Supplied as a kit	Yes
Label carries	manufacturing date, serial number
Distribution end date	2015-12-08

Catalogue Numbers

Catalogue numbers for Stockert Remote Control
Catalogue number	Size	Status
S7019		Withdrawn

Same Product Code

Other products under the same FDA product code
Product	Sold by	Catalogue numbers
Map-iT	Access Point Medical, LLC	420
Woven	Boston Scientific Corporation	126
Inquiry™	Irvine Biomedical. Inc.	122
Webster	Biosense Webster, Inc.	121
Viking™	Boston Scientific Corporation	81
EasyFinder Fixed Curve Diagnostic Catheter	Shanghai Microport EP Medtech Co., Ltd.	56
Supreme™	St. Jude Medical Cardiovascular Division	55
Celsius	Biosense Webster, Inc.	47
Response™	St. Jude Medical Cardiovascular Division	46
Torqr™	Medtronic, Inc.	32
Catheter, Electrode Recording, Or Probe, Electrode Recording	Medtronic, Inc.	27
Lasso NAV	Biosense Webster, Inc.	22

Showing 12 of 112. All products under Catheter, Electrode Recording, Or Probe, Electrode Recording

PMA Approvals

A premarket approval is the full Class III route, granted on clinical evidence rather than on equivalence to an existing device. It is the highest regulatory bar a device of this type can clear.

FDA premarket approvals naming this product code
PMA number	Decision	Trade name	Approved to
P950005	2001-10-05	CELSIUS DIAGNOSTIC/ABLATION DEFLECTABLE TIP CATHETER	Biosense Webster, Inc.

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.