VISBY MEDICAL, INC.

FDA Device Registration & Listing · San Jose, CA, US · Registration 3016608638

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
3016608638
FEI Number
3016608638
Entity Name
VISBY MEDICAL, INC.
City/State/Country
San Jose, CA, US
Establishment Address
3010 North First Street, San Jose, CA 95134, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device,Complaint File Establishment per 21 CFR 820.198
Owner / Operator
Visby Medical, Inc. (Owner Number: 10080245)
Owner / Operator Contact Address
3010 North First Street, San Jose, CA 95134, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K200748
PMA Number
N/A

All Registered Proprietary Names

Visby Medical Sexual Health Click Test

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
LSL Dna-Reagents, Neisseria Microbiology Class 2 866.3390 2021-09-07
QEP Nucleic Acid Detection System For Non-Viral Microorganism(S) Causing Sexually Transmitted Infections Microbiology Class 2 866.3393 2021-09-07
OUY Trichomonas Vaginalis Nucleic Acid Amplification Test System Immunology Class 2 866.3860 2021-09-07
MKZ Dna Probe, Nucleic Acid Amplification, Chlamydia Microbiology Class 1 866.3120 2021-09-07

Official Correspondent

Mike Zatzke

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Visby Medical, Inc.
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 3016608638. Last updated year: 2026. Please use registration number 3016608638 when referencing this establishment in official correspondence.
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