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Telemed Systems, Inc.

USA · Northborough

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Saudi Arabia, South Korea, Israel — 4 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

22listed device types

Class I 8Class II 14Class III 0

plus 27 registration records and 22 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

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

SASaudi ArabiaSFDA

8registered imported devices

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

CACanadaMDALL

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States27 registration records, 22 510(k), 0 PMA, 5 excluded

Brazil0 confirmed, 1 excluded

Saudi Arabia8 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: TeleMed Systems · TELEMED SYSTEMS

FDA 510(k) clearances by year

151990 · K901435

11997 · K974300

11998 · K974312

21999 · K992390

12001 · K010412

22002 · K020379

FDA listed device types

showing 8 of 22

Dislodger, Stone, Basket, Ureteral, Metal 1Endoscopic Injection Needle, Gastroenterology-Urology 1Instrument, Biopsy 1Endoscopic Guidewire, Gastroenterology-Urology 1Forceps, Biopsy, Electric 1Accessories, Cleaning, For Endoscope 1Dislodger, Stone, Biliary 1Endoscopic Grasping/Cutting Instrument, Non-Powered 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K020379	PPD BALLOON DILATATION CATHETER	2002-05-06
US	K013737	MODIFICATION TO: 3-LUMEN DURALON OCCLUSION BALLOON	2002-03-01
US	K010412	FLEXIBLE ENDOSCOPIC SCISSORS	2001-04-02
SA	ME0000003798SFDAA00001	Squeaky Clean Disposable Cleaning Brushes	—
SA	ME0000003800SFDAA00002	Reusable Endoscope Cleaning Brushes	—

Telemed Systems, 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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