CYVEK, INC.

FDA Device Registration & Listing · Wallingford, CT, US · Registration 3040600838

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
3040600838
FEI Number
3040600838
Entity Name
CYVEK, INC.
City/State/Country
Wallingford, CT, US
Establishment Address
5 Technology Dr, Wallingford, CT 06492, US
Establishment Type(s)
Manufacture Device in the United States for Export Only
Owner / Operator
Cyvek, Inc. (Owner Number: 10094000)
Owner / Operator Contact Address
5 Technology Dr, Wallingford, CT 06492, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered Proprietary Names

Ella

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LXG Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use Clinical Chemistry Class 1 862.2050 2025-09-08

Official Correspondent

Roberto Munoz

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Cyvek, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0002-2008 Beckman Coulter Inc 1
FP1000 Cell Preparation System Software versions 1.1 & 1.2, Part Number 624922, for in vitro diagnostic use.
Z-0023-2013 Biomerieux Inc 1
PREVI Isola System, Catalog numbers 29500 and 29500R, bioMerieux, Inc., Durham, NC. Intended to perform the inoculation and streaking of Prepoured Media (PPM) with liquid microbiological samples.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3040600838. Last updated year: 2026. Please use registration number 3040600838 when referencing this establishment in official correspondence.
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