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VYGON S/A.

France · Ecouen

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Israel, Russia — 5 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

32listed device types

Class I 12Class II 20Class III 0

plus 54 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

19registered devices

Class I 7Class II 12

24 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

5active device licences

Class II 5

14 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

7active registrations

Class 2a 4Class 2b 1Class 3 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 States54 registration records, 0 510(k), 0 PMA, 13 excluded

Brazil19 confirmed, 7 excluded

Canada5 confirmed, 3 excluded

Manufacturer names merged into this page: VYGON S A · VYGON S.A. · VYGON S/A.

FDA listed device types

showing 8 of 32

Strap, Head, Gas Mask 1Instrument, Ent Manual Surgical 1Stylet, Tracheal Tube 1Stand, Infusion 1Dispenser, Liquid Medication 1Kit, Surgical Instrument, Disposable 1Regulator, Pressure, Gas Cylinder 1Cannula, Nasal, Oxygen 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80638240018	STERNUM GUARD	Class I
BR	10234400068	PLUGUE ADAPTADOR MACHO PROLONGADOR DE CATETER COM SISTEMA DE VEDACAO P	Class II
BR	10234400180	Seringas para Alimentação enteral - Nutrisafe	Class I
CA	28617	CPAP BOUSSIGNAC SET	Class II
CA	4087	THORACIC CHEST DRAINAGE SYSTEM	Class II
CA	6115	MACINTOSH EPIDURAL BALLOON	Class II

VYGON S/A.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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