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Welldoc, Inc.

USA · Columbia

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 2 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 2Class II 3Class III 0

plus 7 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States7 registration records, 11 510(k), 0 PMA

Manufacturer names merged into this page: WELLDOC · WELLDOC INC.

FDA 510(k) clearances by year

12010

12011

12012

12014

12016

12017

12019

12020

12021

22023

FDA listed device types

Continuous Glucose Monitor Secondary Display 1Calculator, Drug Dose 1Accessories, Pump, Infusion 1Continuous Glucose Monitor Retrospective Data Analysis Software 1Reminder, Medication 1

Market	Identifier	Name	Class / date
US	K222888	BlueStar CGM insulin dose calculator	2023-08-11
US	K230813	BlueStar and BlueStar Rx	2023-07-28
US	K203434	BlueStar Rx	2021-09-08

Welldoc, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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