Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3025749544

FEI Number

3025749544

Entity Name

Tianjin Puli Ark Medical Technology Co., Ltd

City/State/Country

Dongli District Tianjin, CN

Establishment Address

1F and 4F, Building 6, Block B, No. 6 Huafeng Rd., Huaming High-tech Industrial Zone, Dongli District Tianjin 300308, CN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Noah Medical (Owner Number: 10087546)

Owner / Operator Contact Address

2075 Zanker Rd., San Jose, CA 95131, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Galaxy System Galaxy system bronchoscope and accessory kit

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EOQ	Bronchoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4680	2023-03-13

Official Correspondent

Sam Mostafavi

US Agent Details

Sam Mostafavi Business: NOAH MEDICAL Email: sammostafavi@noahmed.com Phone: (650) 6706972

Related Public Records

Same Entity

Noah Medical

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3027205723	NOAH MEDICAL Corp.	Sunnyvale, CA, US
3021325287	NOAH MEDICAL Corp.	San Jose, CA, US
3033628477	NOAH MEDICAL Corp.	San Carlos, CA, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K811059	Pentax Precision Instrument Corp.	PENTAX BRONCHOFIBERSCOPE #FB-15A	1981-05-27
K142934	Covidien	CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved	2015-06-17
K240075	FUJIFILM Healthcare Americas Corporation	FUJIFILM Endoscope Model EB-710XT	2024-02-07

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0025-2020	AURIS HEALTH INC	2	Monarch, Aspirating Biopsy Needle, REF: MBR-000012, Rx Only, UDI: B634MBR0000120

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3005099803	BOSTON SCIENTIFIC CORPORATION	Marlborough, MA, US
8010047	OLYMPUS MEDICAL SYSTEMS CORP.	HACHIOJI-SHI Tokyo, JP
3015970743	CENTERPOINT SYSTEMS LLC	West Valley City, UT, US
3008729892	MEDIPLAST ISRAEL LTD	Yavne Tel Aviv, IL

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3025749544. Last updated year: 2026. Please use registration number 3025749544 when referencing this establishment in official correspondence.