CALCIVIS LIMITED

FDA Device Registration & Listing · Edinburgh Scotland, GB · Registration 3014024087

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
3014024087
FEI Number
3014024087
Entity Name
CALCIVIS LIMITED
City/State/Country
Edinburgh Scotland, GB
Establishment Address
9 Edinburgh BioQuarter 9 Little France Road, Edinburgh Scotland EH164UX, GB
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility
Owner / Operator
Calcivis Limited (Owner Number: 10087618)
Owner / Operator Contact Address
9 Edinburgh BioQuarter 9 Little France Road, Edinburgh, GB-SCT EH164UX, GB
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
P170029

All Registered Proprietary Names

Calcivis Imaging System

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QJX Caries Detection Product With Drug Or Biologic Unknown Class 3 N/A 2023-03-20

Official Correspondent

No official correspondent registered.

US Agent Details

Angela Blackwell Business: Blackwell Device Consulting Email: angela@blackwelldevice.com Phone: (704) 4509934

Related Public Records

Same Entity

Calcivis Limited
View consolidated registration, premarket clearance, and recall records for this applicant.
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014024087. Last updated year: 2026. Please use registration number 3014024087 when referencing this establishment in official correspondence.
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