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Nanova Biomaterials, Inc.

USA · Columbia

✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Taiwan — 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

18listed device types

Class I 13Class II 5Class III 0

plus 21 registration records and 8 510(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

0active device licences

TWTaiwanTFDA

3valid device licences

Class I 1Class II 2

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 States21 registration records, 8 510(k), 0 PMA

Manufacturer names merged into this page: NANOVA BIOMATERIALS INC

FDA 510(k) clearances by year

12014 · K140349

22015 · K152004

22016 · K161174

22017 · K171330

12018 · K172977

FDA listed device types

showing 8 of 18

Screwdriver 1Eraser, Dental Stain 1Bit, Drill 1Syringe, Restorative And Impression Material 1Applier, Hemostatic Clip 1Material, Impression Tray, Resin 1Tap, Bone 1Tray, Surgical, Instrument 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K172977	Nanova 2 Step Etch and Rinse Dental Adhesive, Nanova Etchant Gel	2018-01-16
US	K171330	Nanova Sealant	2017-09-08
US	K163672	Nanova Screw-In Suture Anchor, Nanova Push-In Suture Anchor	2017-05-05

Nanova Biomaterials, Inc.

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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