Home›Canada›ONDINE BIOMEDICAL INC.

ONDINE BIOMEDICAL INC.

Canada · Vancouver

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Canada, Singapore, Australia, Israel — 5 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

4listed device types

Class I 3Class II 0Class III 1

plus 5 registration records and 0 510(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

7active device licences

Class II 7

11 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

3active ARTG entries

Class I 1IIa 2

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States5 registration records, 0 510(k), 0 PMA

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: ONDINE RESEARCH LABORATORIES/ONDINE BIOMEDICAL INC. (US) · ONDINE BIOMEDICAL INC.

Same-named companies — This database also contains companies with near-identical names: ONDINE RESEARCH LABORATORIES/ONDINE BIOMEDICAL INC. (US). Company name alone cannot separate their registrations, so the figures below may include either.

Market	Identifier	Name	Class / date
CA	88952	MRSAID MODEL MW3000 LASER BASE STATION	Class II
CA	89026	ENDOWAVE PHOTODISINFECTION SYSTEM	Class II
CA	69702	PERIOWAVE SYSTEM	Class II

ONDINE BIOMEDICAL INC.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

Similar companies