Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3013572357

FEI Number

3013572357

Entity Name

DONGGUAN SMART MANUFACTURING PARTNER ELECTRONIC COMPANY LIMITED

City/State/Country

Dongguan, Guangdong, CN

Establishment Address

No. 1, 14 Hong Ye Road North, Tangxia Town, Dongguan, Guangdong 523710, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DONGGUAN SMART MANUFACTURING PARTNER ELECTRONIC COMPANY LIMI (Owner Number: 10055235)

Owner / Operator Contact Address

DONGGUAN SMART MANUFACTURING PARTNER ELECTRONIC COMPANY LIMITED, #1, 14 Hong Ye Road North, Tangxia Town, Dongguan,, CN-GD 523710, CN

Initial Importer Flag

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
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2021-11-30
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2019-08-25
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2019-08-02
BZQ	Monitor, Breathing Frequency	Anesthesiology	Class 2	868.2375	2019-08-26

Official Correspondent

Norman Chan

US Agent Details

John Lukie Business: Amphenol Thermometrics Inc. Email: john.lukie@amphenol-sensors.com Phone: (732) 2364913

Related Public Records

Same Entity

DONGGUAN SMART MANUFACTURING PARTNER ELECTRONIC COMPANY LIMI

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
K913749	Edentec Corp.	EDENTRACE AIRFLOW 3171/SLEEP LAB AIRFLOW 3170	1992-07-02
K771407	Research Development Corp.	LUNG VOLUME & PRESSURE MONITOR	1977-08-04
K122223	Philips Medizin Systeme Boeblingen GmbH	NEW: INTELLIVUE CL RESPIRATION POD NEW: SPECIALIZED ASSESSORY: MOBILE CL RESP ATTACHMENT MODIFIED: INTELLIVUE PATIENT MO	2013-04-12

Similar Registrations

Registration Number	Establishment Name	Location
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3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB
3019388613	Masimo Corporation	Irvine, CA, US
3013500228	Amphenol Cable and Interconnect Technologies Asia Pacific Ltd.	Tsimshatsui, Kowloon, HK
3017760831	Hi-P ELECTRONICS (MALAYSIA) SDN. BHD.	Kulim Kedah, MY

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013572357. Last updated year: 2026. Please use registration number 3013572357 when referencing this establishment in official correspondence.