Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3009106214

FEI Number

3009106214

Entity Name

Diversatek Vietnam Company Limited

City/State/Country

Thuan An City Binh Duong, VN

Establishment Address

12-16-18 Street No. 4, Vietnam-Singapore Industrial Park 1, Thuan An City Binh Duong 75000, VN

Establishment Type(s)

Manufacture Medical Device for Another Party (Contract Manufacturer)

Owner / Operator

DIVERSATEK HEALTHCARE INC (Owner Number: 2183446)

Owner / Operator Contact Address

102 EAST KEEFE AVE., --, Milwaukee, WI 53212, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

No proprietary names listed under this establishment.

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
FFT	Electrode, Ph, Stomach	Gastroenterology, Urology	Class 1	876.1400	2024-10-31
MNK	Endoscopic Bite Block	Gastroenterology, Urology	Class 1	876.1500	2010-07-23
FDG	Retractor, Fiberoptic	Gastroenterology, Urology	Class 1	876.4530	2012-02-21
HJM	Transilluminator, Ac-Powered	Ophthalmic	Class 2	886.1945	2012-02-21
FFT	Electrode, Ph, Stomach	Gastroenterology, Urology	Class 1	876.1400	2015-11-17
FGX	Snare, Non-Electrical	Gastroenterology, Urology	Class 1	876.4730	2017-10-06
OCX	Endoscopic Irrigation/Suction System	Gastroenterology, Urology	Class 2	876.1500	2015-03-12
FFT	Electrode, Ph, Stomach	Gastroenterology, Urology	Class 1	876.1400	2024-10-31
KNQ	Dilator, Esophageal	Gastroenterology, Urology	Class 2	876.5365	2022-06-22
KDQ	Bottle, Collection, Vacuum	General Hospital	Class 2	880.6740	2015-02-25
MNL	Accessories, Cleaning Brushes, For Endoscope	Gastroenterology, Urology	Class 1	876.1500	2010-07-23
QIS	Esophageal, Mucosal, Electrical Characterization	Gastroenterology, Urology	Class 2	876.1450	2023-05-03
FFX	System, Gastrointestinal Motility (Electrical)	Gastroenterology, Urology	Class 2	876.1725	2015-12-09

Official Correspondent

LAURA BOLL

US Agent Details

Laura Boll Business: Diversatek Healthcare Co Email: lboll@diversatek.com Phone: (414) 2657620

Related Public Records

Same Entity

DIVERSATEK HEALTHCARE 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
2183446	DIVERSATEK HEALTHCARE INC	Milwaukee, WI, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K883960	Vascular Technology Incorporated	GIPHY MONITOR	1989-10-04
K990935	Pilling Weck Surgical	JACKSON ESOPHAGEAL DILATOR	1999-05-17

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0010-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 260cm Disposable For endoscopy procedures Ref: 2190
Z-0011-2023	Hobbs Medical, Inc.	2	Hobbs Medical Spray Catheter: The Mistifier: 2.6mm 165cm Disposable For endoscopy procedures Ref: 2191

Similar Registrations

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3016854619	ALACER INDUSTRIA ELETRONICA LTDA	Sao Paulo, BR
3018094310	Medtronic Engineering and Innovation Center (MEIC)	Hyderabad Telangana, IN
9710107	GIVEN IMAGING LTD.	Yoqneam Northern, IL
2023374	DIVERSATEK HEALTHCARE INC.	Highlands Ranch, CO, US
3043473562	NADIA-HEALTH INC	Durham, NC, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3009106214. Last updated year: 2026. Please use registration number 3009106214 when referencing this establishment in official correspondence.