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NORTHEAST SCIENTIFIC, INC.

USA · Waterbury

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 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

7listed device types

Class I 2Class II 5Class III 0

plus 11 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

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 States11 registration records, 7 510(k), 0 PMA, 6 excluded

Brazil2 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: NORTHEAST SCIENTIFIC, INC. · NORTHEAST SCIENTIFIC INC.

FDA 510(k) clearances by year

12007

12010

12018

12020

12022

12023

12025

FDA listed device types

Electrosurgical, Cutting & Coagulation & Accessories 1Reprocessed Atherectomy Catheter 1Reprocessed Intravascular Ultrasound Catheter 1Electrosurgical, Cutting & Coagulation Accessories, Laparoscopic & Endoscopic, Reprocessed 1Catheter, Ultrasound, Intravascular 1Tray, Surgical 1Retractor 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K250592	NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)	2025-05-12
US	K223026	NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter	2023-02-03
US	K220171	NES Reprocessed 0.9mm Turbo Elite Laser Atherectomy Catheter	2022-07-01
BR	80553579001	Deslocador Esofágico	Class II
BR	82791919001	DESLOCADOR ESOFÁGICO ESOSURE	Class II

NORTHEAST SCIENTIFIC, 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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