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Vygon Us, LLC

USA · Norristown

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 3 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

28listed device types

Class I 5Class II 23Class III 0

plus 51 registration records and 7 510(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

6active device licences

Class II 2Class III 2Class IV 2

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States51 registration records, 7 510(k), 0 PMA, 11 excluded

Brazil0 confirmed, 8 excluded

Canada6 confirmed, 2 excluded

Manufacturer names merged into this page: VYGON USA · VYGON US DBA VYGON NEURO · VYGON US DBA VYGON CORPORATION, DBA CHURCHILL MEDICAL SYSTEMS

FDA 510(k) clearances by year

22004 · K033704

12006 · K052475

22018 · K181208

12022 · K212370

12024 · K243361

FDA listed device types

showing 8 of 28

Peripheral Catheter Insertion Kit 1Port & Catheter, Implanted, Subcutaneous, Intravascular 1Percutaneous Atrial Catheter Kit 1Needle, Hypodermic, Single Lumen 1Tube, Feeding 1Midline Catheter 1Nerve Block Tray 1Attachment, Breathing, Positive End Expiratory Pressure 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243361	Nutrifit	2024-12-19
US	K212370	Leaderflex Mini and Leaderflex Nano	2022-08-29
US	K181208	Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter	2018-11-02
CA	5011	BLOMQUIST EXTERNAL TISSUE EXTENDER	Class II
CA	10045	HUNTER SUTURE CORD	Class III
CA	10197	HUNTER TENDON IMPLANTS	Class III

Vygon Us, LLC

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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