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Genadyne Biotechnologies, Inc.

USA · Hicksville

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, South Korea, Australia, Hong Kong, Israel — 8 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

13listed device types

Class I 8Class II 5Class III 0

plus 50 registration records and 21 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class II 5

12 including historic records

SASaudi ArabiaSFDA

4registered imported devices

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

CACanadaMDALL

1active device licences

Class II 1

15 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

16active ARTG entries

Class I 1IIa 4IIb 8Class Is (sterile) 3

HKHong KongMDACS

7valid listings

Class II 3Class III 4

ILIsraelAMAR

3registrations

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 States50 registration records, 21 510(k), 0 PMA

Brazil5 confirmed, 0 excluded

Saudi Arabia4 confirmed, 0 excluded

Canada1 confirmed, 0 excluded

Manufacturer names merged into this page: Genadyne Biotechnologies, Inc. · GENADYNE BIOTECHNOLOGIES, INC. · GENADYNE BIOTECHNOLOGIES INC. · Genadyne Biotechnologies Inc.

FDA 510(k) clearances by year

22008

12009

12010

12011

12012

12014

42015

12017

12018

12019

12020

22022

12023

22024

12026

FDA listed device types

showing 8 of 13

Ventilator, Non-Continuous (Respirator) 1Negative Pressure Wound Therapy Powered Suction Pump 1Pump, Breast, Powered 1Mesh, Surgical, Polymeric 1Mattress, Air Flotation, Alternating Pressure 1Mattress, Flotation Therapy, Non-Powered 1Armrest, Wheelchair 1Accessories, Wheelchair 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K253429	Genadyne ASTRA NPWT	2026-03-12
US	K243225	Nasal Pillow Mask - Small (NNPM-01/ Nefes S); Nasal Pillow Mask - Medium (NNPM-02/ Nefes M); Nasal Pillow Mask - Large (NNPM-03/ Nefes L)	2024-12-31
US	K233614	Genadyne DUO NPWT	2024-12-23
BR	10306849017	Canister XLR8+	Class II
BR	10306849018	UNO - Sistema de Terapia por Pressão Negativa para o Tratamento de Fer	Class II
BR	10306849016	XLR8+ Sistema de Terapia por Pressão Negativa para o Tratamento de Fer	Class II
SA	ME0000005842SFDAA00059	Silgen Ag 5mL	—
SA	ME0000005842SFDAA00060	Silgen Ag 10mL	—
CA	66209	PRESSURE BED AIR PUMPS	Class II

Genadyne Biotechnologies, 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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