Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3016908271

FEI Number

3016908271

Entity Name

Nextern Vietnam LLC

City/State/Country

Ben Cat District Binh Duong, VN

Establishment Address

C1B-5D, Lot C-1B-CN, DE5 Road, My Phuoc 3 IP, Ben Cat District Binh Duong 820000, VN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

Nextern Innovation, Inc (Owner Number: 10037078)

Owner / Operator Contact Address

10601 Fountains Drive, Maple Grove, MN 55369, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

DermaSensor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QZS	Software-Aided Adjunctive Diagnostic Device For Use By Physicians On Lesions Suspicious For Skin Cancer	General, Plastic Surgery	Class 2	878.1830	2024-04-23

Official Correspondent

Caroline Byrd

US Agent Details

Caroline Byrd Business: NEXTERN INNOVATION, INC Email: regulatory@nextern.com Phone: (651) 2032100

Related Public Records

Same Entity

Nextern Innovation, Inc

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

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3023531666	Nextern Costa Rica Ltd.	Cartago, CR
3031976597	Nextern	Maple Grove, MN, US

Similar Registrations

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3028606342	OMAY(GUANGZHOU) MED TECHNOLOGIES CO., LTD	Guangzhou Guangdong, CN
3038274470	BRAINMATTERZ, INC	McKinney, TX, US
3012404174	LABORATORIO CHIMICO FARMACEUTICO A. SELLA SRL.	Schio Vicenza, IT
3042364673	NEURALYTIX LLC	Fruita, CO, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3016908271. Last updated year: 2026. Please use registration number 3016908271 when referencing this establishment in official correspondence.