HomeCanadaO-Two Medical Technologies Inc.

O-Two Medical Technologies Inc.

Canada · Brampton ON · www.otwo.com
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, Australia, Israel — 8 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
21listed device types
Class I 12Class II 9Class III 0
plus 33 registration records and 8 510(k)
UKUnited KingdomMHRA PARD
3registered device records
Class IIa 2Class IIb 1
BRBrazilANVISA
1registered devices
Class 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
23active device licences
Class II 21Class III 2
51 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
3device registrations
CLASS B 2CLASS C 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
10active ARTG entries
Class I 1IIa 2IIb 7
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
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.

European Union2,643 raw hits, 300 excluded, 0 confirmed. Large result set — only the first 300 verified
United States33 registration records, 8 510(k), 0 PMA, 7 excluded
United Kingdom3 confirmed, 17 excluded
Brazil1 confirmed, 0 excluded
Canada23 confirmed, 0 excluded
Manufacturer names merged into this page: O-TWO MEDICAL TECHNOLOGIES, INC. · O-TWO MEDICAL TECHNOLOGIES INC. · OTWO MEDICAL TECHNOLOGIES INC.

Regulatory identity

UK responsible person
Meditelle Ltd

Company information

Country
Canada
City
Brampton ON
Website
www.otwo.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesMedical Devices & Clinical EquipmentEmergency, Rescue & Disaster Medicine

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.

Business registration

LEI
54930096GKIPNEI1JJ20
Registration status
Active
Registered address
7575 Kimbel Street, Mississauga, L5S 1C8
Registry record updated
2023-08-08

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

22005
12009
12010
12011
12012
12015
12018

FDA listed device types

showing 8 of 21
Mixer, Breathing Gases, Anesthesia Inhalation 1Monitor, Airway Pressure (Includes Gauge And/Or Alarm) 1Nebulizer (Direct Patient Interface) 1Attachment, Breathing, Positive End Expiratory Pressure 1Valve, Non-Rebreathing 1Ventilator, Emergency, Manual (Resuscitator) 1Oximeter 1Ventilator, Emergency, Powered (Resuscitator) 1

Registration details (sample)

MarketIdentifierNameClass / date
UK37704O-Two Medical Single-Use Breathing circuit with Scavenger Hose, Monitoring line, and Adapter with MouthpieceClass IIa
UK46232Universal Face MaskClass IIa
UK16953Nitrous Oxide/Oxygen Analgesic Gas Mixing and Delivery System – eAdvantageClass IIb
USK173205Equinox Advantage2018-08-29
USK141595O-TWO E700,O-TWO E600,O-TWO E5002015-03-16
USK113687EQUINOX RELIEVE2012-04-30
BR81474710014Sistema de CPAP O-Two de Circuito AbertoClass II
CA14687O-TWO SYSTEM PRESSURE REGULATORSClass II
CA18737GENESIS II RESUSCITATION SYSTEMClass III
CA31786DISPOSABLE BAG VALVE MASK RESUSCITATORClass II

Similar companies

Acime Frame SAS
France · markets 5
Acoresmed Co., Ltd.
China · markets 1
AICHHORN AND CO EOOD
Bulgaria · markets 1
AUG MEDICAL SP. Z O.O.
Poland · markets 3
China Qingdao Bright Medical Manufacturing Co.
China · markets 6
Chrisofix AG
Switzerland · markets 2
Is this your company? Claim the page, add information or report a data error.Claim / report an error →