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Home›USA›VYGON CORPORATION D.B.A. VYGON USA

VYGON CORPORATION D.B.A. VYGON USA

USA · Lansdale
✓ 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
28listed device types
Class I 5Class II 23Class III 0
plus 51 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
8active device licences
Class II 3Class III 5
67 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 States51 registration records, 4 510(k), 0 PMA, 12 excluded
Brazil0 confirmed, 8 excluded
Canada8 confirmed, 3 excluded
Manufacturer names merged into this page: VYGON USA · VYGON CORPORATION D.B.A. VYGON USA
Same-named companies — This database also contains companies with near-identical names: VYGON USA. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Lansdale

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

FDA 510(k) clearances by year

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)

MarketIdentifierNameClass / date
USK243361Nutrifit2024-12-19
USK212370Leaderflex Mini and Leaderflex Nano2022-08-29
USK181208Vygon Midline 3 Fr SL Catheter; Vygon Midline 4 Fr SL Catheter; Vygon Midline 5 Fr DL Catheter2018-11-02
CA13892EPICUTANEO CAVA CATHETERClass III
CA80870NUTRILINE PIC CATHETER WITH INTRODUCERSClass III
CA80871NUTRILINE PIC CATHETER KITS WITH INTRODUCERSClass III

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