Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014341624

FEI Number

3014341624

Entity Name

DONGGUAN KEPLER SPECIAL CABLING COMPANY LIMITED

City/State/Country

Dongguan Guangdong, CN

Establishment Address

Room 201,301,401 and 501, Building No.3, Xintai Gold Jewelry Industrial Center, No.10 Huanhu Road, Houjie Town, Dongguan Guangdong 523960, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Dongguan Kepler Special Cabling Company Limited (Owner Number: 10057512)

Owner / Operator Contact Address

Room 201,301,401 and 501, Building No.3, Xintai Gold Jewelry Industrial Center, No.10 Huanhu Road, Houjie Town, Dongguan, CN-GD 523960, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Multi-Link Vital Signs

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2020-11-27
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2020-11-27
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2021-08-19
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2019-12-02
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2020-05-31
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2019-11-27
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2018-07-10

Official Correspondent

Tommy Liu

US Agent Details

Scott Hayden Business: Kepler SignalTek LTD Email: scott.hayden@keplersignaltek.com Phone: (802) 3738695

Related Public Records

Same Entity

Dongguan Kepler Special Cabling Company Limited

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

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K880323	Medtronic Vascular	MEDTRONIC MODEL 5411 SURGICAL CABLE ADAPTOR	1988-03-22
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

Registration Number	Establishment Name	Location
3017528618	ATRILITY MEDICAL, INC.	Madison, WI, US
3017619000	SHENZHEN REDY-MED TECHNOLOGY CO., LTD.	Shenzhen Guangdong, CN
2939520	VOLCANO CORPORATION	Rancho Cordova, CA, US
3017636737	STERIS Corporation de Republica Dominicana, S.R.L.	Santo Domingo, DO
3004859241	BOSTON SCIENTIFIC CORPORATION	La Aurora Heredia, CR

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014341624. Last updated year: 2026. Please use registration number 3014341624 when referencing this establishment in official correspondence.