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ANGIODYNAMICS, INC. ALSO D.B.A. AS NAVILYST MEDICAL , INC.

USA · Marlborough

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, South Korea, Australia, Russia — 6 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

35510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 35 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

5registered devices

Class II 5

21 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

15active device licences

Class II 8Class III 7

46 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

20active ARTG entries

Class III 5IIa 6IIb 7Class Is (sterile) 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

2active registrations

Class 2b 2

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 States0 registration records, 35 510(k), 0 PMA

Brazil5 confirmed, 0 excluded

Canada15 confirmed, 0 excluded

Manufacturer names merged into this page: ANGIODYNAMICS, INC. ALSO D.B.A. AS NAVILYST MEDICAL , INC. · NAVILYST MEDICAL, INC. · NAVILYST MEDICAL, INC · ANGIODYNAMICS, INC. ALSO DBA NAVILYST MEDICAL, INC. · ANGIODYNAMICS, INC. ALSO DBA NAVILYST MEDICAL, INC

Same-named companies — This database also contains companies with near-identical names: ANGIODYNAMICS, INC. ALSO DBA NAVILYST MEDICAL, INC., Navilyst Medical, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K163452	PICC Maximal Barrier Nursing Kit	2017-02-03
US	K161866	BioFlo Midline Catheter	2016-09-08
US	K151239	NMI DUAL PORT II	2016-06-06
BR	80208360024	MANIFOLDS NAMIC	Class II
BR	80208360025	MANIFOLD ANGIOGRÁFICO NAMIC	Class II
BR	80208360027	VAXCEL MINI STICK	Class II
CA	77840	NANOKNIFE BIPOLAR ELECTRODE PROBE	Class II
CA	18482	ELECTROSURGICAL RF GENERATOR	Class III
CA	67611	INTELLIFLOW INFUSION PUMP SYSTEM	Class II

ANGIODYNAMICS, INC. ALSO D.B.A. AS NAVILYST MEDICAL , INC.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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