HomeUSAViant Medical, Inc.

Viant Medical, Inc.

USA · Fort Wayne
✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Israel — 9 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
69listed device types
Class I 38Class II 30Class III 1
plus 108 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
3registered devices
Class I 3
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
23registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
2active device licences
Class II 2
5 including historic records
TWTaiwanTFDA
5valid device licences
Class I 5
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
2GMP quality-system certificates
Import 2
AUAustraliaTGA ARTG
17active ARTG entries
Class I 10IIa 7
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
4registrations
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 States108 registration records, 0 510(k), 0 PMA, 7 excluded
Brazil3 confirmed, 0 excluded
Saudi Arabia23 confirmed, 0 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: Viant Medical, LLC · Viant Medical, Inc. · Viant Medical SUZHOU EPZ Co., Ltd · Viant Medical, Inc · VIANT MEDICAL, LLC · VIANT MEDICAL INC.

Company information

Country
USA
City
Fort Wayne

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 listed device types

showing 8 of 69
Template 1Elevator 1Forceps 1Hook, Bone 1Rasp 1Chisel, Surgical, Manual 1Clamp 1Dispenser, Cement 1

Registration details (sample)

MarketIdentifierNameClass / date
BR80145901935Bi-Mentum – Instrumentais ViantClass I
BR80005430625Instrumental ViantClass I
BR80044680444Conjunto de Instrumentais para EscareaçãoClass I
SAME0000018349SFDAA00004Standard Acetabular Reamer
SAME0000018349SFDAA00015OFFSET IMPACTOR TIP
CA67779REAMER HEADSClass II
CA98015TORQUE LIMITING ATTACHMENTClass II

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