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DOMINION BIOLOGICALS LIMITED

Canada · Dartmouth

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, 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

pendingnot queried

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

1registered devices

Class I 1

5 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

7active device licences

Class III 7

19 including historic records

TWTaiwanTFDA

13valid device licences

Class II 11Class III 2

SGSingaporeHSA SMDR

3device registrations

CLASS C 1CLASS D 2

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

4active ARTG entries

IVD Class 3 2IVD Class 4 2

HKHong KongMDACS

4valid listings

IVD C 1IVD D 3

ILIsraelAMAR

3registrations

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 States0 registration records, 0 510(k), 0 PMA, 3 excluded

Brazil1 confirmed, 0 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: DOMINION BIOLOGICALS LTD · DOMINION BIOLOGICALS, LTD. · DOMINION BIOLOGICALS LIMITED

Registration details (sample)

Market	Identifier	Name	Class / date
BR	10077090115	PEG Potentiator	Class I
CA	30581	ANTI-HUMAN GLOBULIN (RABBIT)	Class III
CA	30582	BLOOD GROUPING REAGENT ANTI-P1 (GOAT)	Class III
CA	30584	SEROLOGICAL REAGENT - BOVINE ALBUMIN	Class III

DOMINION BIOLOGICALS LIMITED

Registrations by market

How these numbers were verified

Company information

Registration details (sample)

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