Home›USA›GENESEE BIOMEDICAL, INC.

GENESEE BIOMEDICAL, INC.

USA · Denver

✓ Record-verifiedregistrations found in 4 markets

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

13listed device types

Class I 5Class II 8Class III 0

plus 17 registration records and 14 510(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

2active device licences

Class II 2

3 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

1active ARTG entries

Class I 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States17 registration records, 14 510(k), 0 PMA, 1 excluded

Brazil0 confirmed, 3 excluded

Canada2 confirmed, 0 excluded

Manufacturer names merged into this page: GENESEE BIOMEDICAL, INC. · GENESEE BIOMEDICAL INC.

FDA 510(k) clearances by year

22005

22007

22009

12010

12016

12019

12020

12023

12024

12025

12026

FDA listed device types

showing 8 of 13

Instruments, Surgical, Cardiovascular 1Sizer, Heart-Valve, Prosthesis 1Retractor 1Stabilizer, Heart 1Accessories, Catheter 1Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 1Bottle, Collection, Vacuum 1Set, Administration, Intravascular 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K252917	ATLAAS (Atraumatic Left Atrial Appendage System) (AD)	2026-05-22
US	K250859	TransForm McCarthy Mitral Annuloplasty Ring (TF)	2025-07-25
US	K232599	TransForm McCarthy Mitral Annuloplasty Ring (TF)	2024-04-09
CA	63347	INTRA-ART CORONARY ARTERY OCCLUDERS (STERILE)	Class II
CA	63349	ANASTOSURE EPICARDIAL STABILIZER FEET	Class II

GENESEE BIOMEDICAL, INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

Similar companies