Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030142846

FEI Number

3030142846

Entity Name

MEDICALTEK CO. LTD

City/State/Country

Taichung, TW

Establishment Address

4F, No. 26, Keya Rd., Daya Dist., Taichung 428, TW

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

MedicalTek Co. Ltd (Owner Number: 10092169)

Owner / Operator Contact Address

4F, No. 26, Keya Rd., Daya Dist., Taichung, TW-TXG 428, TW

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K234096

PMA Number

N/A

All Registered Proprietary Names

MonoStereo

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
EOB	Nasopharyngoscope (Flexible Or Rigid)	Ear, Nose, Throat	Class 2	874.4760	2024-12-11

Official Correspondent

Shen Ching Yeh

US Agent Details

Benzy Arazy Business: Medes USA C/O Matan Arazy Email: Medes@Arazygroup.com Phone: (415) 9921126

Related Public Records

Same Entity

MedicalTek 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 3030142846. Last updated year: 2026. Please use registration number 3030142846 when referencing this establishment in official correspondence.