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NOVOSCI CORP.

USA · Conroe

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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

12listed device types

Class I 2Class II 10Class III 0

plus 18 registration records and 4 510(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

14active device licences

Class II 14

26 including historic records

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 States18 registration records, 4 510(k), 0 PMA

Canada14 confirmed, 0 excluded

Manufacturer names merged into this page: NOVOSCI CORP.

FDA 510(k) clearances by year

22004 · K033270

22007 · K072499

FDA listed device types

showing 8 of 12

Heat-Exchanger, Cardiopulmonary Bypass 1Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass 1Filter, Blood, Cardiopulmonary Bypass, Arterial Line 1Defoamer, Cardiopulmonary Bypass 1Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 1Sucker, Cardiotomy Return, Cardiopulmonary Bypass 1Oxygenator, Cardiopulmonary Bypass 1Clamp, Vascular 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K072499	NOVOFLO CATHETER LT	2007-10-30
US	K063355	D-LINE CATHETER ST, DOUBLE LUMEN ST; EXTRA FLOW	2007-07-27
US	K033270	NOVOSCI READY SYSTEM, MODEL RS-200	2004-02-13
CA	7298	PREBYPASS FILTERS (BARD FILE # 0008)	Class II
CA	9815	CUSTOM PAC	Class II
CA	28371	SURGIMEDICS/LIFESTREAM OPTICAL FIBERS	Class II

NOVOSCI CORP.

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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