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Home›Canada›BIO NUCLEAR DIAGNOSTICS, INC.

BIO NUCLEAR DIAGNOSTICS, INC.

Canada · Toronto
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Canada — 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
7listed device types
Class I 7Class II 0Class III 0
plus 7 registration records and 25 510(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
8active device licences
Class II 7Class III 1
28 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 States7 registration records, 25 510(k), 0 PMA, 32 excluded
Brazil0 confirmed, 3 excluded
Saudi Arabia0 confirmed, 1 excluded
Canada8 confirmed, 4 excluded
Manufacturer names merged into this page: BIO NUCLEAR DIAGNOSTICS, INC. · BIO NUCLEAR DIAGNOSTICS INC.
Same-named companies — This database also contains companies with near-identical names: Nuclear Diagnostics, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Canada
City
Toronto

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

21977
51978
21979
11980
31981
21983
11985
31986
11987
11993
11994
12000
12002
12008

FDA listed device types

Container, Specimen, Sterile 1Container, Specimen, Non-Sterile 1Micro Pipette 1Shaker/Stirrer 1Applicator, Absorbent Tipped, Non-Sterile 1Slides, Microscope 1Tourniquet, Nonpneumatic 1

Registration details (sample)

MarketIdentifierNameClass / date
USK081522BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY2008-12-05
USK021656HERMES HDAQ ACQUISITION STATION AND HERMES WORKSTATION, VER. 3.42002-06-13
USK002782HERMES HD AQ ACQUISITION STATION AND HERMES WORKSTATION2000-12-05
CA31551HCG ONE STEP PREGNANCY TEST DEVICEClass II
CA61637LIFE-FORCE MASSAGERClass II
CA80018TRANS OS (ENDO)CERVICAL SAMPLERClass II

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