Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010160538

FEI Number

3010160538

Entity Name

SHENZHEN WELL ELECTRIC CO. LIMITED

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

1-3F, No. 407, HeDongCun, HengKeng, GuanCheng Community, GuanHu Street, Longhua District, Shenzhen Guangdong 518110, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Well Electric Co. Limited (Owner Number: 10042286)

Owner / Operator Contact Address

1-3F, No. 407 HeDongCun, HengKeng, GuanCheng Commuinty,, GuanHu Street, Longhua District, Shenzhen, CN-GD 518110, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

AquilaScan WDTP-10 Drug Analyzer AquilaScan WDTP-80 Drug Analyzer Alcovisor Mars BT Breath Alcohol Analyzer Alcovisor Satellite Breath Alcohol Analyzer Alcovisor Click Breath Alcohol Analyzer Alcovisor Pluto Breath Alcohol Analyzer Alcovisor Jupiter X Breath Alcohol Analyzer Alcotorch V9 Alcovisor Phoebus Alcotorch V6 Alcovisor Jupiter Breath Alcohol Analyzer Alcovisor Mark X Alcovisor Deimos Alcovisor Saturn Alcovisor Titan Alcovisor Alpha Alcovisor Beta Alcovisor Mars Breath Alcohol Analyzer Alcovisor Mercury Breath Alcohol Analyzer Alcotorch V10 Alcovisor Mark V Breath Alcohol Analyzer Alcovisor Gamma Alcotorch V11 Alcovisor Venus Breath Alcohol Analyzer Alcovisor Canopus Alcotorch V12

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JJC	Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use	Clinical Chemistry	Class 1	862.2150	2016-07-20
DJZ	Devices, Breath Trapping, Alcohol	Clinical Toxicology	Class 1	862.3050	2012-11-08

Official Correspondent

No official correspondent registered.

US Agent Details

Siobhan Sheeran Business: PAS Systems International, Inc Email: ssheeran@scramsystems.com Phone: (513) 3654126

Related Public Records

Same Entity

Shenzhen Well Electric Co. Limited

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3012275122	C4 Development Limited	Kwun Tong, HK

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K760211	Instrumentation Laboratory CO	ANALYZER, GLUCOSE/UREA/CREATININE	1976-08-26

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1219913	Siemens Healthcare Diagnostics Inc.	E Walpole, MA, US
3003741796	DIRUI INDUSTRIAL CO., LTD.	CHANGCHUN Jilin, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010160538. Last updated year: 2026. Please use registration number 3010160538 when referencing this establishment in official correspondence.