Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008770957

FEI Number

3008770957

Entity Name

WELLDOC

City/State/Country

Columbia, MD, US

Establishment Address

10221 Wincopin Cir Ste 150, Columbia, MD 21044, US

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Welldoc (Owner Number: 10034724)

Owner / Operator Contact Address

10221 Wincopin Circle, Suite 150, Columbia, MD 21044, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

Welldoc App Welldoc Rx App for Diabetes in Pregnancy and Insulin Pump Users Health Optimizer for Rare Condition Members Lilly Health Personalized Medicine and Health Platform MDLIVE Health Coaching Welldoc App Welldoc Rx App for Diabetes in Pregnancy and Insulin Pump Users BlueStar Welldoc Diabetes Conifer Connect Diabetes BlueStar Rx Conifer Connect Diabetes Rx Welldoc Diabetes Rx Welldoc Rx App BlueStar Health Optimizer BlueStarRx Welldoc Rx App for Diabetes in Pregnancy and Insulin Pump Users

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
PHV	Continuous Glucose Monitor Retrospective Data Analysis Software	Clinical Chemistry	Class 1	862.2120	2025-07-15
NXQ	Reminder, Medication	Physical Medicine	Class 1	890.5050	2024-10-31
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2021-12-29
NDC	Calculator, Drug Dose	Anesthesiology	Class 2	868.1890	2021-12-29
MRZ	Accessories, Pump, Infusion	General Hospital	Class 2	880.5725	2021-12-29
PJT	Continuous Glucose Monitor Secondary Display	Clinical Chemistry	Class 2	862.1350	2024-12-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Welldoc

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 3008770957. Last updated year: 2026. Please use registration number 3008770957 when referencing this establishment in official correspondence.