Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014485094

FEI Number

3014485094

Entity Name

MATERNA MEDICAL

City/State/Country

Mountain View, CA, US

Establishment Address

2495 Hospital Drive, Suite 300, Mountain View, CA 94040, US

Establishment Type(s)

Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Materna Medical (Owner Number: 10084276)

Owner / Operator Contact Address

2495 Hospital Drive, Suite 300, Mountain View, CA 94040, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K211959

PMA Number

N/A

All Registered Proprietary Names

Milli Vaginal Dilator

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
HDX	Dilator, Vaginal	Obstetrics/Gynecology	Class 2	884.3900	2022-02-02

Official Correspondent

Kelly Ashfield

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Materna Medical

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 3014485094. Last updated year: 2026. Please use registration number 3014485094 when referencing this establishment in official correspondence.