Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025349182

FEI Number

3025349182

Entity Name

SHENZHEN ZHIXIN BIOMEDICAL TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

1001, Lifotronic Tower, No. 8, Qiuzhi East Road, Guancheng Community, Guanhu Street, Longhua, Shenzhen Guangdong 518110, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Shenzhen Zhixin Biomedical Technology Co., Ltd. (Owner Number: 10085980)

Owner / Operator Contact Address

B113K, Comprehensive Building, No. 3 Sub-park, Leibozhongcheng Life Science Park, No. 22 Jinxiu East Road, Jinsha Community, Kengzi Street, Pingshan District, Shenzhen, CN-GD 518122, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

S4 Disposable Laryngoscope Blades Tecme RC3A Reusable Laryngoscope Blades Tecme R4 Reusable Laryngoscope Blades S1 Disposable Laryngoscope Blades Tecme RC1 Reusable Laryngoscope Blades RC4 Reusable Laryngoscope Blades R2 Reusable Laryngoscope Blades RL00 Reusable Laryngoscope Blades RC5A Reusable Laryngoscope Blades RC2 Reusable Laryngoscope Blades RC4A Reusable Laryngoscope Blades Tecme S1 Disposable Laryngoscope Blades RL0 Reusable Laryngoscope Blades R3 Reusable Laryngoscope Blades Tecme S2 Disposable Laryngoscope Blades Tecme RC2 Reusable Laryngoscope Blades Tecme S3 Disposable Laryngoscope Blades S3 Disposable Laryngoscope Blades Tecme RC2A Reusable Laryngoscope Blades RL1 Reusable Laryngoscope Blades Tecme RL1 Reusable Laryngoscope Blades Tecme RC5A Reusable Laryngoscope Blades VL Pro Video Laryngoscope Tecme RC4A Reusable Laryngoscope Blades RC5 Reusable Laryngoscope Blades VL SE Video Laryngoscope Tecme VL Video Laryngoscope RC1 Reusable Laryngoscope Blades R4 Reusable Laryngoscope Blades RC3 Reusable Laryngoscope Blades Tecme RL00 Reusable Laryngoscope Blades S2 Disposable Laryngoscope Blades Tecme RC1A Reusable Laryngoscope Blades RC1A Reusable Laryngoscope Blades VL Video Laryngoscope Tecme RC3 Reusable Laryngoscope Blades Tecme S4 Disposable Laryngoscope Blades RC2A Reusable Laryngoscope Blades Tecme R2 Reusable Laryngoscope Blades Tecme RC4 Reusable Laryngoscope Blades Tecme VL Pro Video Laryngoscope Tecme RC5 Reusable Laryngoscope Blades Tecme VL SE Video Laryngoscope RC3A Reusable Laryngoscope Blades Tecme R3 Reusable Laryngoscope Blades Tecme RL0 Reusable Laryngoscope Blades

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CCW	Laryngoscope, Rigid	Anesthesiology	Class 1	868.5540	2022-11-01

Official Correspondent

Avery Chen

US Agent Details

He Zhongmin He Email: zhongmin.he@gmail.com Phone: (408) 8592530

Related Public Records

Same Entity

Shenzhen Zhixin Biomedical Technology Co., Ltd.

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

View Entity Profile →

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0144-2024	Covidien	1	Stolen McGRATH MAC Video Laryngoscopes, REF: 301-000-000
Z-0168-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-017-000, Sterile EO, Rx Only
Z-0169-2024	Covidien	1	McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025349182. Last updated year: 2026. Please use registration number 3025349182 when referencing this establishment in official correspondence.