Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3006991053

FEI Number

3006991053

Entity Name

LONGFIAN SCITECH CO., LTD.

City/State/Country

Baoding Hebei, CN

Establishment Address

Building B5, Kechuang Branch, National University Science Park,, No. 666 Lixing Street,, Baoding Hebei 071051, CN

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LONGFIAN SCITECH CO., LTD. (Owner Number: 10047648)

Owner / Operator Contact Address

Building B5, Kechuang Branch, National University Science Park,, No. 666 Lixing Street,, Baoding, CN-HE 071051, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K213210

PMA Number

N/A

All Registered Proprietary Names

JAY-5 JAY-5AW SOC5100

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2014-10-16
CAX	Flowmeter, Tube, Thorpe, Back-Pressure Compensated	Anesthesiology	Class 1	868.2340	2023-06-05
CAW	Generator, Oxygen, Portable	Anesthesiology	Class 2	868.5440	2023-06-05

Official Correspondent

Baozhu Shi

US Agent Details

Jun Peng Business: P&L Scientific Inc. Email: jpeng@plscientificinc.com Phone: (305) 3456018

Related Public Records

Same Entity

LONGFIAN SCITECH 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
K003939	Invacare Corp.	VENTURE HOME FILL II, MODEL IOH 200	2001-03-21
K942357	Healthdyne, Inc.	H-500 ALLIANCE OXYGEN CONCENTRATOR	1994-05-27
K042262	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATOR, MODEL 6323A-OM-10	2004-09-10
K003472	Sequal Technologies, Inc.	INTEGRA OXYGEN CONCENTRATORS MODEL 6400-OM	2001-06-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0038-2007	Sunrise Medical	2	DeVilbiss iFill Personal Oxygen Station model number 535D.

Similar Registrations

Registration Number	Establishment Name	Location
3004964590	AVOX SYSTEMS	Lancaster, NY, US
3008841036	Oxus America, Inc.	Orion Township, MI, US
3016809216	GUANGZHOU LIFE LIGHT ELECTRONIC TECHNOLOGY CO., LTD.	Guangzhou City Guangdong, CN
9611451	FISHER & PAYKEL HEALTHCARE, LTD.	EAST TAMAKI Auckland, NZ
3013095415	VENTEC LIFE SYSTEMS, INC.	Bothell, WA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006991053. Last updated year: 2026. Please use registration number 3006991053 when referencing this establishment in official correspondence.