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EMED TECHNOLOGIES CORPORATION

USA · Eldorado Hills

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, Canada, Australia — 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

5listed device types

Class I 0Class II 5Class III 0

plus 13 registration records and 11 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

7registered devices

Class II 7

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

3active device licences

Class II 3

6 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

IIa 2

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 States13 registration records, 11 510(k), 0 PMA, 1 excluded

Brazil7 confirmed, 2 excluded

Saudi Arabia0 confirmed, 1 excluded

Canada3 confirmed, 0 excluded

Manufacturer names merged into this page: EMED TECHNOLOGIES CORPORATION · EMED TECHNOLOGIES CORPORATION (NOVO ENDEREÇO)

FDA 510(k) clearances by year

12012

22014

12015

12016

12018

22022

12023

12024

12025

FDA listed device types

Introducer, Syringe Needle 1Immunoglobulin G (Igg) Infusion System 1Pump, Infusion 1Set, Administration, Intravascular 1Tubing, Fluid Delivery 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251105	Tetra (TM-20); Tetra (TM-50)	2025-12-22
US	K240148	SCIg60 Infusion System	2024-02-16
US	K230883	VersaPump Infusion System	2023-11-28
BR	80351249026	Sistema de Infusão VersaPump.	Class II
BR	80351240025	SISTEMA DE INFUSÃO SCIg60	Class II
BR	80351240024	Dispositivo Soft-Glide®	Class II
CA	91025	DETRUSET INTRAVESICAL ELECTRICAL STIMULATION CATHETER	Class II
CA	92418	CONNECT IV FLOW REGULATOR I.V. SETS	Class II
CA	99069	EMED SOLUBLE HEMOSTATIC GAUZE PAD	Class II

EMED TECHNOLOGIES CORPORATION

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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