HomeCanadaDiagnostics Biochem Canada Inc.

Diagnostics Biochem Canada Inc.

Canada · London ON · www.dbc-labs.com
✓ Record-verifiedregistrations found in 8 marketsEU SRN CA-MF-000032449

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, South Korea, Israel, Russia — 8 overseas markets. EU UDI-DI records ≥5, the first 300 verified individually. 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
≥5UDI-DI device records
IVD general 5
large result set — only the first 300 records were verified, so the real figure is at least this
USUnited StatesFDA openFDA
16listed device types
Class I 15Class II 1Class III 0
plus 17 registration records and 6 510(k)
UKUnited KingdomMHRA PARD
41registered device records
IVD general 41
BRBrazilANVISA
29registered devices
Class II 29
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
15active device licences
Class II 15
71 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
IVD import 1
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
1active registrations
Class 1 1
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 Union715 raw hits, 295 excluded, 5 confirmed. Large result set — only the first 300 verified
United States17 registration records, 6 510(k), 0 PMA, 4 excluded
United Kingdom41 confirmed, 2 excluded
Brazil29 confirmed, 0 excluded
Canada15 confirmed, 0 excluded
Manufacturer names merged into this page: DIAGNOSTICS BIOCHEM CANADA, INC. · DIAGNOSTICS BIOCHEM CANADA INC. · DIAGNOSTICS BIOCHEM CANADA INC · DIAGNOSTICS BIOCHEM CANANDA INC · DBC-DIAGNOSTICS BIOCHEM CANADA INC. · DBC - DIAGNOSTICS BIOCHEM CANADA

Regulatory identity

EU manufacturer SRN
CA-MF-000032449
EU authorised representative
MedEnvoy Global BV
UK responsible person
MedEnvoy UK Limited

Company information

Country
Canada
City
London ON
Website
www.dbc-labs.com
Product categories
Clinical Diagnostics & Therapeutic TechnologiesLaboratory, IVD & DiagnosticsClinical chemistry & immunoassays

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

Legal name
V BIOCHEM CANADA INC.
Corporation number
17554591
Registration status
Active
Legal form
Canada Business Corporations Act
Incorporated
2025-12-17
Registered address
26 Dunster Crescent, Brampton, ON, L6T 3J7

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

FDA 510(k) clearances by year

11978 · K781310
11980 · K801729
11983 · K832297
11987 · K864966
12002 · K014120
12003 · K030730

FDA listed device types

showing 8 of 16
Radioimmunoassay, Estriol 1Radioimmunoassay, Follicle-Stimulating Hormone 1Radioimmunoassay, Progesterone 1Radioimmunoassay, 17-Hydroxyprogesterone 1Radioimmunoassay, Estradiol 1Radioimmunoassay, Glucagon 1Radioimmunoassay, Estrone 1Radioimmunoassay, Total Estrogens, Nonpregnancy 1

Registration details (sample)

MarketIdentifierNameClass / date
EUD-++B261CANRA4600K6IVD general
EUD-++B261CANL4260DAIVD general
EUD-++B261CANE420DBIVD general
EUD-++B261CANFTE260Q9IVD general
UK6357717a-hydroxyprogesterone (17a-OHP) ELISAIVD general
UK58896Adiponectin ELISAIVD general
UK63578Aldosterone ELISAIVD general
USK030730FREE TESTOSTERONE ENZYMEIMMUNOASSAY (EIA) KIT2003-08-18
USK014120TESTOSTERONE BY ENZYMEIMMUNOASSAY (EIA)2002-02-08
USK864966ESTRONE ANALYSIS PRODUCTS RADIOIMMUNOASSAY ESTRONE1987-01-09
BR80048490058DIRECT FREE TESTOSTERONE ELISA KITClass II
BR80048490059DIRECT TOTAL TESTOSTERONE ELISA KITClass II
BR1030039046317alfa-HYDROXYPROGESTERONE (17alfa-OHP)Class II
CA417DIHYDROTESTOSTERONE (DHT) KIT RIAClass II
CA418ALDOSTERONE KIT RIAClass II
CA1202DIHYDROTESTOSTERONE (DHT) KIT (C.T. RIA)Class II

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