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Claronav, Inc.

Canada · Toronto

✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Australia, Israel — 6 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

5listed device types

Class I 0Class II 5Class III 0

plus 7 registration records and 6 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

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

1 including historic records

TWTaiwanTFDA

3valid device licences

Class I 2Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

2active ARTG entries

Class I 1IIa 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

3registrations

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 States7 registration records, 6 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: ClaroNav Inc. · CLARONAV INC.

FDA 510(k) clearances by year

12016 · K161406

12017 · K163439

12022 · K210947

12024 · K233563

22025 · K243053

FDA listed device types

Ear, Nose, And Throat Stereotaxic Instrument 1System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations 1Dental Stereotaxic Instrument 1Neurological Stereotaxic Instrument 1Dental Navigation System 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K243053	Navient Image Guided Navigation System (ENT) (955-NC-NC)	2025-06-20
US	K241327	Navient Image Guide Navigation System (955-NC-NC), Cranial	2025-02-05
US	K233563	Navident	2024-07-25
BR	80686360436	MicronMapper	Class I
BR	80686360258	Sistema Navident	Class II

Claronav, 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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