Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3010071455

FEI Number

3010071455

Entity Name

LeadtekBiomed Inc.

City/State/Country

New Taipei City, TW

Establishment Address

2F, No. 4 , Alley 11, Lane 327, Sec. 2, Chung San Rd., Chung Ho Dist., New Taipei City 23585, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

LeadtekBiomed Inc. (Owner Number: 10095207)

Owner / Operator Contact Address

18F, No.166, Jian 1st Rd., Zhonghe Dist., New Taipei City, TW-NWT 235, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K210032

PMA Number

N/A

All Registered Proprietary Names

Alvital LeadtekBiomed Alvital LeadtekBiomed

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-02-04
DQA	Oximeter	Cardiovascular	Class 2	870.2700	2026-02-04

Official Correspondent

Terry Kuan

US Agent Details

Matthew Dryden Email: Matt.Dryden@promedic.cc Phone: (239) 3076060

Related Public Records

Same Entity

LeadtekBiomed Inc.

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
K903523	Hewlett-Packard Co.	HP MODEL M1020A, ARTERIAL OXYGEN SAT/PLETH MODULE	1990-10-23
K973147	Nellcor Puritan Bennett, Inc.	NPB-295 PULSE OXIMETER	1997-11-14
K231243	Guangdong Genial Technology Co., Ltd.	Finger Clip Pulse Oximeter	2023-10-31
K971628	Somanetics Corp.	SOMANETICS INVOS 3100A CEREBRAL OXIMETER (INVOS)	1997-10-10
K153184	Shenzhen Caremed Medical Technology Co., Ltd.	Caremed Reusable & Disposable SPO2 Sensors	2017-01-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0020-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20 (US) N, Part Number CS08651
Z-0022-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-02
Z-0023-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	CAPNOSTREAM 20P (US) N - ROHS, Part Number CS08651-03
Z-0028-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M, Part Number CS08653
Z-0029-2019	Oridion Medical 1987 Ltd. Har Hotzvim Industrial	2	Capnostream20 (US) M W/PRINTER, Part Number CS08659

Similar Registrations

Registration Number	Establishment Name	Location
3014652024	CEA GROUP INTERNATIONAL CO.,LTD	Wenzhou Zhejiang, CN
1062836	DIGICARE BIOMEDICAL TECHNOLOGY, INC.	BOYNTON BEACH, FL, US
3013250653	MASIMO CORPORATION	Irvine, CA, US
3013418500	Quintana Supply, a division of Thomas Scientific	Haverhill, MA, US
9614470	RADIOMETER BASEL AG	BASEL Basel-Stadt, CH

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3010071455. Last updated year: 2026. Please use registration number 3010071455 when referencing this establishment in official correspondence.