HomeUSAInnovize LLC

Innovize LLC

USA · St Paul MN · www.innovize.com
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Saudi Arabia — 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
0UDI-DI device records
USUnited StatesFDA openFDA
13listed device types
Class I 7Class II 2Class III 1unclassified 3
plus 19 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
0registered device records
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
2registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
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 States19 registration records, 0 510(k), 0 PMA
Saudi Arabia2 confirmed, 0 excluded
Manufacturer names merged into this page: Innovize · Innovize, Inc.

Company information

Country
USA
City
St Paul MN
Website
www.innovize.com
Product categories
Manufacturing, Lifecycle & Obsolescence ManagementCDMO (Contract Development and Manufacturing Organization)General Product Development, Development & Design Transfer

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 13
Dressing, Wound, Drug 1Oral Wound Dressing 1Hemostatic Wound Dressing Without Thrombin Or Other Biologics 1Continuous Glucose Monitor, Implanted, Adjunctive Use 1Marker, Skin 1Splint, Intranasal Septal 1Cushion, Pad, Denture, Wax Impregnated Cotton, Over The Counter 1Tape, Orthopedic 1

Registration details (sample)

MarketIdentifierNameClass / date
SAME0000002639SFDAA00003MYI Eye Patch
SAME0000002639SFDAA00002Coverclude

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