ZENTECH MANUFACTURING, INC

FDA Device Registration & Listing · Baltimore, MD, US · Registration 3006529712

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3006529712
FEI Number
3006529712
Entity Name
ZENTECH MANUFACTURING, INC
City/State/Country
Baltimore, MD, US
Establishment Address
6980 Tudsbury Rd, Baltimore, MD 21244, US
Establishment Type(s)
Manufacture Medical Device for Another Party (Contract Manufacturer)
Owner / Operator
Zentech Manufacturing, Inc (Owner Number: 10042060)
Owner / Operator Contact Address
6980 Tudsbury Road, Baltimore, MD 21244, US
Initial Importer Flag
N
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
MQB Solid State X-Ray Imager (Flat Panel/Digital Imager) Radiology Class 2 892.1680 2026-03-05
EAP Unit, X-Ray, Intraoral Dental Class 2 872.1810 2026-03-05

Official Correspondent

Clint Fleming

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Zentech Manufacturing, 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
K070563 Vidar Systems Corp. VIDAR VISION 2000 2007-03-16
K190691 Pixxgen Corporation Pixx2430 Digital Diagnostic X-Ray Receptor Panel 2019-04-04
K150150 Rayence Co., Ltd. 1717SGN / 1717SCN Digital Flat Panel X-ray Detector 2015-03-27
K140771 Philips Medical Systems Dmc GmbH PHILIPS ELEVA WORKSPOT 2014-04-25

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2009 Toshiba American Medical Systems Inc 2
Toshiba Infinix fluoroscopy DFP-8000D Digital Radiography System with version 3.40 or higher software. Controller for Infinix interventional angiography systems.
Z-0031-2007 AGFA Corp. 2
CR DX-S, Image Intensified Fluoroscopic X-ray system.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3006529712. Last updated year: 2026. Please use registration number 3006529712 when referencing this establishment in official correspondence.
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