Home›Canada›EPOCAL, INC.

EPOCAL, INC.

Canada · Ottawa

✓ Record-verifiedregistrations found in 10 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Hong Kong, Israel, Russia — 10 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

13listed device types

Class I 3Class II 10Class III 0

plus 10 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class I 1Class II 1

3 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

0active device licences

1 including historic records

TWTaiwanTFDA

1valid device licences

Class I 1

SGSingaporeHSA SMDR

1device registrations

CLASS C 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

3active ARTG entries

IVD Class 1 2IVD Class 2 1

HKHong KongMDACS

1valid listings

IVD C 1

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

2active registrations

Class 2a 2

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, 7 510(k), 0 PMA

Brazil2 confirmed, 0 excluded

Manufacturer names merged into this page: EPOCAL, INC. · Epocal Inc · EPOCAL INC.

Business registration

Legal name: EPOCAL INC.
Corporation number: 10477265
Registration status: Active
Legal form: Canada Business Corporations Act
Incorporated: 2017-11-01
Registered address: 1577 North Service Road East, Oakville, ON, L6H 0H6

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

12006 · K061597

12009 · K090109

22010 · K093297

12012 · K113726

12018 · K171247

12020 · K200107

FDA listed device types

showing 8 of 13

Glucose Oxidase, Glucose 1Electrode, Ion Specific, Potassium 1Device, Hematocrit Measuring 1Electrode, Ion-Specific, Chloride 1Electrode, Ion Specific, Urea Nitrogen 1Electrode, Ion Specific, Sodium 1Electrode, Ion Specific, Calcium 1Ph Rate Measurement, Carbon-Dioxide 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K200107	epoc Blood Analysis System	2020-06-05
US	K171247	epoc Blood Urea Nitrogen Test, epoc Total Carbon Dioxide Test	2018-01-17
US	K113726	EPOC CHLORIDE TEST AND EPOC CREATININE TEST	2012-10-05
BR	10345162193	EPOC BLOOD ANALYSIS SYSTEM	Class II
BR	10345162215	CARE FILL CAPILLARY TUBES	Class I