GENERAL MEDITECH, INC.

FDA Device Registration & Listing · Shenzhen Guangdong, CN · Registration 3006147705

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006147705
FEI Number
3006147705
Entity Name
GENERAL MEDITECH, INC.
City/State/Country
Shenzhen Guangdong, CN
Establishment Address
South Office 4/F,Kezhi 1st.Rd west,, Science Park Nanshan,, Shenzhen Guangdong 518057, CN
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
GENERAL MEDITECH, INC. (Owner Number: 10028583)
Owner / Operator Contact Address
South Office 4/F,Kezhi 1st.Rd west,, Science Park Nanshan,, Shenzhen, CN-GD 518057, CN
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K092970
PMA Number
N/A

All Registered Proprietary Names

G3N G3M G3S G3R Model: G3C, G3D, G3F, G3G, G3H, G3L and G2A

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 2010-03-23

Official Correspondent

Javier Fan

US Agent Details

Marco Mu Business: MID-LINK INTERNATIONAL CO., LTD Email: us.agent@mid-link.net Phone: (702) 2095185

Related Public Records

Same Entity

GENERAL MEDITECH, INC.
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
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 3006147705. Last updated year: 2026. Please use registration number 3006147705 when referencing this establishment in official correspondence.
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