Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013596024

FEI Number

3013596024

Entity Name

Amphenol Medical Technologies (Dongguan) Co., Ltd.

City/State/Country

Dongguan Guangdong, CN

Establishment Address

No.2 Xinhu Industrial 1st Street, Qiaotou, Dongguan Guangdong 523533, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Amphenol Critical Medical Technologies, LLC (Owner Number: 10053883)

Owner / Operator Contact Address

9586 Distribution Avenue, Suite F, San Diego, CA 92121, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

CABLE,MULTI FUNCTION,DPLX SHLD,7.5FT Bovie Cord:Reusable Bipolar Forceps Cord Kendall DL 12 Pin Adapter ECG lead, Multi and Monolead ECG lead, reusable CABLE ECG X2 3/5-LD PHILIPS AHA 20CM/9IN Cable SpaceLabs

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2018-06-01
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2017-06-20
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-05-25
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2017-06-28
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2024-12-19
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2019-07-17
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2020-12-14
HGM	System, Monitoring, Perinatal	Obstetrics/Gynecology	Class 2	884.2740	2018-07-30
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2017-12-19
GXY	Electrode, Cutaneous	Neurology	Class 2	882.1320	2019-08-06
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2018-06-06
DRG	Transmitters And Receivers, Physiological Signal, Radiofrequency	Cardiovascular	Class 2	870.2910	2023-09-08
MSX	System, Network And Communication, Physiological Monitors	Cardiovascular	Class 2	870.2300	2023-09-08
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-09-08
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2023-09-08
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2023-09-08
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2020-04-07
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2018-06-01
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2018-06-01
DSI	Detector And Alarm, Arrhythmia	Cardiovascular	Class 2	870.1025	2018-06-01
DXG	Computer, Diagnostic, Pre-Programmed, Single-Function	Cardiovascular	Class 2	870.1435	2018-06-01
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2018-06-01
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2018-06-01
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2020-02-20
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2018-06-01
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2017-06-20
QMS	Adjunctive Open Loop Fluid Therapy Recommender	Cardiovascular	Class 2	870.5600	2025-04-07
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-05-25
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-07-03
ISN	Cable	Physical Medicine	Class 1	890.3420	2017-12-18
NIK	Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (Crt-D)	Unknown	Class 3	N/A	2019-07-22
LWS	Implantable Cardioverter Defibrillator (Non-Crt)	Unknown	Class 3	N/A	2019-07-22
OJX	Drug Eluting Permanent Left Ventricular (Lv) Pacemaker Electrode	Unknown	Class 3	N/A	2019-07-22
NVZ	Pulse Generator, Permanent, Implantable	Unknown	Class 3	N/A	2019-07-22
NKE	Pulse Generator, Pacemaker, Implantable, With Cardiac Resynchronization (Crt-P)	Unknown	Class 3	N/A	2019-07-22
OSR	Pacemaker/Icd/Crt Non-Implanted Components	Unknown	Class 3	N/A	2019-07-22
LWP	Implantable Pulse Generator, Pacemaker (Non-Crt)	Unknown	Class 3	N/A	2019-07-22
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2017-12-18
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2017-06-20
LDD	Dc-Defibrillator, Low-Energy, (Including Paddles)	Cardiovascular	Class 2	870.5300	2017-06-20
MKJ	Automated External Defibrillators (Non-Wearable)	Cardiovascular	Class 3	870.5310	2017-06-20
LIX	Aid, Cardiopulmonary Resuscitation	Cardiovascular	Class 2	870.5210	2017-06-20
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2017-12-19
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2017-06-20
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2017-12-18
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2017-12-18
DPZ	Oximeter, Ear	Cardiovascular	Class 2	870.2710	2017-12-18
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2017-12-20
IKD	Cable, Electrode	Physical Medicine	Class 2	890.1175	2017-01-19
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2017-12-19
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2025-06-26
DSA	Cable, Transducer And Electrode, Patient, (Including Connector)	Cardiovascular	Class 2	870.2900	2026-01-26
CCI	Analyzer, Gas, Nitrogen, Gaseous-Phase	Anesthesiology	Class 2	868.1690	2017-12-19
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1700	2017-12-19
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2017-12-19
NHQ	Analyzer, Gas, Isoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2017-12-19
CBS	Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)	Anesthesiology	Class 2	868.1620	2017-12-19
DOA	Radioimmunoassay, Digoxin (125-I), Goat Antibody, Anion Exchange, Resin Sep.	Clinical Toxicology	Class 2	862.3320	2017-12-19
DXJ	Display, Cathode-Ray Tube, Medical	Cardiovascular	Class 2	870.2450	2017-12-19
NHP	Analyzer, Gas, Sevoflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2017-12-19
NHO	Analyzer, Gas, Desflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2017-12-19
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2017-12-19
BSE	Analyzer, Gas, Helium, Gaseous-Phase	Anesthesiology	Class 2	868.1640	2017-12-19
GWQ	Full-Montage Standard Electroencephalograph	Neurology	Class 2	882.1400	2017-12-19
DPT	Probe, Blood-Flow, Extravascular	Cardiovascular	Class 2	870.2120	2017-12-19
CCL	Analyzer, Gas, Oxygen, Gaseous-Phase	Anesthesiology	Class 2	868.1720	2017-12-19
CBQ	Analyzer, Gas, Enflurane, Gaseous-Phase (Anesthetic Concentration)	Anesthesiology	Class 2	868.1500	2017-12-19
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2017-12-19
JEG	Analyzer, Gas, Argon, Gaseous-Phase	Anesthesiology	Class 2	868.1075	2017-12-19
DSK	Computer, Blood-Pressure	Cardiovascular	Class 2	870.1110	2017-12-19
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2017-12-19
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	Anesthesiology	Class 2	868.1400	2017-12-19
QMS	Adjunctive Open Loop Fluid Therapy Recommender	Cardiovascular	Class 2	870.5600	2023-07-13
QAQ	Adjunctive Predictive Cardiovascular Indicator	Cardiovascular	Class 2	870.2210	2023-07-13
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2023-07-13
DSB	Plethysmograph, Impedance	Cardiovascular	Class 2	870.2770	2023-07-13
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-07-13
DXN	System, Measurement, Blood-Pressure, Non-Invasive	Cardiovascular	Class 2	870.1130	2023-07-13
MUD	Oximeter, Tissue Saturation	Cardiovascular	Class 2	870.2700	2023-07-13
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2023-07-13
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2018-06-01
QAQ	Adjunctive Predictive Cardiovascular Indicator	Cardiovascular	Class 2	870.2210	2023-09-18
DQK	Computer, Diagnostic, Programmable	Cardiovascular	Class 2	870.1425	2023-09-18
DQE	Catheter, Oximeter, Fiber-Optic	Cardiovascular	Class 2	870.1230	2023-09-18
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2017-06-20
MWI	Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.2300	2017-06-20
DPS	Electrocardiograph	Cardiovascular	Class 2	870.2340	2023-06-07
MWJ	Electrocardiograph, Ambulatory (Without Analysis)	Cardiovascular	Class 2	870.2800	2018-06-25

Official Correspondent

No official correspondent registered.

US Agent Details

Lamont Rohde Business: Amphenol Critical Medical Technologies, LLC Email: lamont.rohde@amphenol-cmt.com Phone: (602) 7503539

Related Public Records

Same Entity

Amphenol Critical Medical Technologies, LLC

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013500228	Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.	Tsimshatsui, Kowloon, HK
3009746061	Integra Biotechnical, SA de CV	Tijuana Baja California, MX

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K993974	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR	2000-02-22
K182075	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)	2018-12-10
K051628	Draeger Medical Systems, Inc.	INFINITY MONITORS WITH SCIO MODIFICATIONS	2005-07-20
K972535	Odam	MAGLIFE C	1998-01-13
K170567	Remote Diagnostic Technologies , Ltd.	Tempus Pro Patient Monitor	2017-07-06

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2025	Philips North America Llc	2	IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Z-1027-2026	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Z-1321-2023	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R
Z-1666-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]
Z-1729-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013596024. Last updated year: 2026. Please use registration number 3013596024 when referencing this establishment in official correspondence.