Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014335097

FEI Number

3014335097

Entity Name

TAIAN DALU MEDICAL INSTRUMENT CO.,LTD.

City/State/Country

Taian Shandong, CN

Establishment Address

No.3988 Yitianmen Street, Hi-tech Zone, Taian Shandong 271000, CN

Establishment Type(s)

Manufacture Medical Device,Manufacture Medical Device for Another Party (Contract Manufacturer),Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Taian Dalu Medical Instrument Co.,Ltd. (Owner Number: 10061508)

Owner / Operator Contact Address

No.3988 Yitianmen Street, Hi-tech Zone, Taian, CN-SD 271000, CN

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

FPF-S1 DL-DF01 Electronic Peak Flow Meter Nose clip

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZH	Meter, Peak Flow, Spirometry	Anesthesiology	Class 2	868.1860	2024-04-29
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2024-01-29

Official Correspondent

Angelia Wang

US Agent Details

Leeyeo Kee Business: Regrek LLC Email: regrek.cs@hotmail.com Phone: (302) 6089028

Related Public Records

Same Entity

Taian Dalu Medical Instrument 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
K050853	Card Guard Scientific Survival , Ltd.	PMP4 SPIROPRO	2005-05-04
K123945	Monaghan Medical Corp.	STRIVE DUAL ZONE PEAK FLOW METER	2013-04-17

Similar Registrations

Registration Number	Establishment Name	Location
3008505660	eResearchTechnology GmbH	Estenfeld Bavaria, DE
1000604079	VINCENT MEDICAL MANUFACTURING. CO., LTD.	KOWLOON, HK
9614860	MIR - MEDICAL INTERNATIONAL RESEARCH S.P.A.	ROMA, IT
1317346	MONAGHAN MEDICAL CORP.	Plattsburgh, NY, US
9612777	TRUDELL MEDICAL INTERNATIONAL	LONDON Ontario, CA

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014335097. Last updated year: 2026. Please use registration number 3014335097 when referencing this establishment in official correspondence.