EMI (DONGGUAN) ASIA LIMITED

FDA Device Registration & Listing · Dongguan City Guangdong, CN · Registration 3017422354

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
3017422354
FEI Number
3017422354
Entity Name
EMI (DONGGUAN) ASIA LIMITED
City/State/Country
Dongguan City Guangdong, CN
Establishment Address
Lot No. 5, Chuangying Road Dongcheng Section,, Dongcheng District,, Dongguan City Guangdong 523013, CN
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Registrar Corp (Owner Number: 10088978)
Owner / Operator Contact Address
144 Research Drive, Hampton, VA 23666, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2023-10-25
LDD Dc-Defibrillator, Low-Energy, (Including Paddles) Cardiovascular Class 2 870.5300 2023-10-25
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2023-10-25
DQA Oximeter Cardiovascular Class 2 870.2700 2023-10-25
MKJ Automated External Defibrillators (Non-Wearable) Cardiovascular Class 3 870.5310 2023-10-25
CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase Anesthesiology Class 2 868.1400 2023-10-25
DRT Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) Cardiovascular Class 2 870.2300 2023-10-25
DSK Computer, Blood-Pressure Cardiovascular Class 2 870.1110 2023-10-25
DRO Pacemaker, Cardiac, External Transcutaneous (Non-Invasive) Cardiovascular Class 2 870.5550 2023-10-25

Official Correspondent

No official correspondent registered.

US Agent Details

David Lennarz Business: Registrar Corp Email: David.Lennarz@registrarcorp.com Phone: (757) 2240177

Related Public Records

Same Entity

Registrar Corp
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
9616139 CHEMIGLAS CORP. Yangsan Gyeongnam, KR
3011534533 SPES MEDICA S.P.A Genova Liguria, IT
3007034808 Barber of Sheffield Ltd Barnsley, South Yorkshire, GB

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K100940 Andon Health Co, Ltd. FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 2010-06-29
K251581 Shenzhen Hingmed Medical Instrument Co., Ltd. Wearable Ambulatory Blood Pressure Monitor (WBP-02A) 2026-02-13
K200521 Health & Life Co., Ltd. Full Automatic(NIBP) Blood Pressure Monitor 2020-06-12
K152003 Andon Health Co, Ltd. iHealth BP3L Wireless Blood Pressure Monitor 2015-09-24
K952827 Sein Electronics Co., Ltd. FULL AUTO WRIST BLOOD PRESSURE METER MODEL SE-5000 1996-11-14

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0032-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001
Z-0033-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE AUTOMATIC DIGITAL BLOOD PRESSURE UNIT, REF MDS1001U.
Z-0034-2025 MEDLINE INDUSTRIES, LP Northfield 2
MEDLINE Automatic Digital Blood Pressure Monitor, REF MDS1001UT.
Z-0557-2025 Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom 2
Tempus LS-Manual Defibrillator Model 00-3020 The Tempus LS-Manual is a defibrillator that can deliver a shock in manual or Pacemaker mode
Z-0564-2021 Remote Diagnostic Technologies Ltd. PAVILION C2, ASHWOOD PARK ASHWOOD WAY Basingstoke United Kingdom 2
Tempus LS - Manual Defibrillator, Model Number: 00-3020 Software Version: 1.3.4 - Product Usage: The device is intended to be used in the following environmental: - Primarily in pre-hospital care and transport applications (including ambulances, fixed and rotary wing aircraft).

Similar Registrations

Registration Number Establishment Name Location
1062836 DIGICARE BIOMEDICAL TECHNOLOGY, INC. BOYNTON BEACH, FL, US
3006543075 SHANGHAI KODEA ECONOMIC AND TRADE DEVELOPMENT LIMI SHANGHAI, CN
3011912849 BODYTRACE San Jose, CA, US
3036999955 ZYBS CONSULTING LLC DBA ZYBS MEDICAL GROUP, DBA ZYBS MEDICAL Largo, MD, US
3019575688 AKTIIA SA Neuchatel, CH
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3017422354. Last updated year: 2026. Please use registration number 3017422354 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.