Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3045063899

FEI Number

3045063899

Entity Name

SHENZHEN SANYI PIONEER TECHNOLOGY CO., LTD.

City/State/Country

Shenzhen Guangdong, CN

Establishment Address

Room 527, Lianfu Huating, No.188 Qingquan Road, YuCui Community, Longhua Street, Longhua District Shenzhen, Shenzhen Guangdong 518110, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

SHENZHEN SANYI PIONEER TECHNOLOGY CO., LTD. (Owner Number: 10095732)

Owner / Operator Contact Address

Room 527, Lianfu Huating, No.188 Qingquan Road, YuCui Community, Longhua Street, Longhua District Shenzhen, Shenzhen, CN-GD 518110, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K964092

PMA Number

N/A

All Registered Proprietary Names

TMS Comfort Series CPAP Nasal Pillows Mask, Elbow, Frame Set

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZD	Ventilator, Non-Continuous (Respirator)	Anesthesiology	Class 2	868.5905	2026-04-20

Official Correspondent

Vivian Lin

US Agent Details

Clare Ho Email: cfrhealthcare@foxmail.com Phone: (929) 4102964

Related Public Records

Same Entity

SHENZHEN SANYI PIONEER TECHNOLOGY 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
K792722	Novametrix Medical Systems, Inc.	NOVAMETRIX CPAP NASAL CANNULA	1980-01-24
K082979	Resmed, Ltd.	S8 ADVANCE	2009-01-02
K203126	Resmed Pty , Ltd.	S10 Kirra	2020-12-18

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0009-2020	TELEFLEX-MORRISVILLE	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold Catalog # 2691 for use with ventilators.
Z-0020-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold, REF 1030, RX Only, UDI: 04710810093562
Z-0021-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus Bubble PAP Valve with 12.5 cm H2O Pressure Relief Manifold, REF 1002, Rx Only, UDI: 24710810093559
Z-0022-2020	Galemed Corporation 87 Wu-Jia Li-Gong 2nd Road I-Lan Taiwan	2	Babi.Plus 12.5 cm H2O Pressure Relief Manifold with Gas Supply Tube and Oxygen Sensor Port, REF 2691, Rx Only, UDI: 04710810100802

Similar Registrations

Registration Number	Establishment Name	Location
3012667060	HMC Premedical S.p.A.	Medolla Modena, IT
3013505405	BMC (Tianjin) Medical Co., Ltd.	Wuqing District Tianjin, CN
3033530343	BMC INVESTMENT HOLDING LIMITED	Hong Kong, HK
3017684630	ResMed Asia Pte. Ltd.	Singapore South West, SG
3042507287	3B MEDICAL INC	W Jefferson, OH, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3045063899. Last updated year: 2026. Please use registration number 3045063899 when referencing this establishment in official correspondence.