Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3042828169

FEI Number

3042828169

Entity Name

SAN NON BIOTECHNOLOGY CO., LTD.

City/State/Country

New Taipei City, TW

Establishment Address

1F., No.10, Ln. 366, Sec. 2, Zhongshan Rd., Zhonghe Dist., New Taipei City 235, TW

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer),Manufacture Medical Device

Owner / Operator

San Non Biotechnology Co., Ltd. (Owner Number: 10094929)

Owner / Operator Contact Address

1F., No.10, Ln. 366, Sec. 2, Zhongshan Rd., Zhonghe Dist., New Taipei City, TW-NWT 235, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

KetoBM

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JIN	Nitroprusside, Ketones (Urinary, Non-Quant.)	Clinical Chemistry	Class 1	862.1435	2026-01-06

Official Correspondent

No official correspondent registered.

US Agent Details

Shu-Chen Cheng Business: ROC Chinese-European Industrial Research Society Email: ceirs.jen@msa.hinet.net Phone: (614) 5888168

Related Public Records

Same Entity

San Non Biotechnology Co., Ltd.

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

View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3042828169. Last updated year: 2026. Please use registration number 3042828169 when referencing this establishment in official correspondence.