Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3020924771

FEI Number

3020924771

Entity Name

SHENZHEN WITLEAF MEDICAL ELECTRONICS CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 1201, Building 1, Senyang Electronic Technology Park, West Area, Guangming High-tech Park, Tianliao Community, Yutang Street, Guangming District, Shenzhen Guangdong 518132, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Witleaf Medical Electronics Co., Ltd. (Owner Number: 10087479)

Owner / Operator Contact Address

Room 1201, Building 1, Senyang Electronic Technology Park, West Area, Guangming High-tech Park, Tianliao Community, Yutang Street, Guangming District, Shenzhen, CN-GD 518132, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Handheld Pulse Oximeter CH-100; Wellness Oximeter Handheld Pulse Oximeter (model: WIT-S100, WIT-S300, CH-100B) Fingertip Pulse Oximeter (model: WIT-S200, WIT-S400) Nasopharyngeal airway for oxygenation and capnography (model: iway 13, iway 15)

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PGJ	Oximeter, Wellness	Cardiovascular	Class 2	870.2700	2023-08-17
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-03-04
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2023-03-04
BTQ	Airway, Nasopharyngeal	Anesthesiology	Class 1	868.5100	2023-11-29

Official Correspondent

No official correspondent registered.

US Agent Details

Linda Chen Business: Dynasty Medical Consulting Inc. Email: usagent@chonconn.com Phone: (832) 3809688

Related Public Records

Same Entity

Shenzhen Witleaf Medical Electronics Co., Ltd.

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
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10
K153184	Shenzhen Caremed Medical Technology Co., Ltd.	Caremed Reusable & Disposable SPO2 Sensors	2017-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

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3013116677	PROSOMNUS SLEEP TECHNOLOGIES	Pleasanton, CA, US
3007858728	Shenzhen Hexin ZONDAN Medical Equipment Co., Ltd	Shenzhen Guangdong, CN

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3020924771. Last updated year: 2026. Please use registration number 3020924771 when referencing this establishment in official correspondence.