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Home›USA›Bio-Med Device, Inc.

Bio-Med Device, Inc.

USA · Guilford
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
6listed device types
Class I 2Class II 4Class III 0
plus 10 registration records and 20 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
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
3active device licences
Class II 3
6 including historic records
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 States10 registration records, 20 510(k), 0 PMA, 340 excluded
Brazil1 confirmed, 132 excluded
Saudi Arabia0 confirmed, 34 excluded
Canada3 confirmed, 48 excluded
Manufacturer names merged into this page: BIO-MED DEVICES, INC. · BIO-MED DEVICES, INC
Same-named companies — This database also contains companies with near-identical names: BIO-MED DEVICES, INC.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Guilford

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 510(k) clearances by year

51980
21981
11982
21983
31987
11988
21990
11995
12018
12022
12025

FDA listed device types

Analyzer, Gas, Oxygen, Gaseous-Phase 1Mixer, Breathing Gases, Anesthesia Inhalation 1Ventilator, Continuous, Facility Use 1Monitor, Airway Pressure (Includes Gauge And/Or Alarm) 1Set, Tubing And Support, Ventilator (W Harness) 1Circuit, Breathing (W Connector, Adaptor, Y Piece) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK251245OxyMinder Pro (10310)2025-08-11
USK213948OxyMinder2022-03-17
USK173973TV-1002018-07-20
BR80102519183Blender Misturador de Ar/OxigênioClass II
CA7759VENTILATION MONITORClass II
CA7761M-2 OXYGEN TEMPERATURE MONITORClass II
CA7769ARID AIR COMPRESSORClass II

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