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Accriva Diagnostics, Inc.

USA · San Diego

✓ 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

14listed device types

Class I 2Class II 12Class III 0

plus 34 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

13registered devices

Class I 1Class II 12

23 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

7active device licences

Class II 2Class III 5

17 including historic records

TWTaiwanTFDA

15valid device licences

Class I 5Class II 10

SGSingaporeHSA SMDR

7device registrations

CLASS C 7

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

IVD import 3

AUAustraliaTGA ARTG

6active ARTG entries

IVD Class 1 1IVD Class 2 4IIa 1

HKHong KongMDACS

7valid listings

Class II 1IVD C 6

ILIsraelAMAR

11registrations

RURussiaRoszdravnadzor

5active registrations

Class 1 1Class 2a 4

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 States34 registration records, 3 510(k), 0 PMA

Brazil13 confirmed, 0 excluded

Canada7 confirmed, 0 excluded

Manufacturer names merged into this page: Accriva Diagnostics, Inc. · ACCRIVA DIAGNOSTICS, INC. · ACCRIVA DIAGNOSTICS · ACCRIVA DIAGNOSTICS INC.

FDA 510(k) clearances by year

12019 · K193041

12021 · K202101

12023 · K223352

FDA listed device types

showing 8 of 14

Protamine Sulphate 1Activated Whole Blood Clotting Time 1Instrument, Coagulation 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1Device, Bleeding Time 1System, Multipurpose For In Vitro Coagulation Studies 1Plasma, Coagulation Control 1System, Automated Platelet Aggregation 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K223352	Tenderfoot	2023-03-02
US	K202101	GEM Hemochron 100 System, GEM Hemochron 100 Activated Clotting Time Plus Test (ACT+), GEM Hemochron 100 Low Range Activated Clotting Time Test (ACT-LR), directCHECK ACT+ Whole Blood Control, Level 1 and Level 2, directCHECK ACT-LR Whole Blood Control, Level 1 and Level 2	2021-12-29
US	K193041	Hemochron Signature Elite	2019-11-22
BR	80003610545	Oxímetro Avox 1000E	Class II
BR	80003610544	CO-Oxímetro Avox 4000	Class II
BR	80003610549	Dispositivos para Incisão Accriva	Class II
CA	65802	HEMOCHRON JR. SIGNATURE WHOLE BLOOD MICROCOAGULATION SYSTEM	Class III
CA	65803	DIRECTCHECK WHOLE BLOOD CONTROL	Class III
CA	66117	HEMOCHRON JR. SIGNATURE + WHOLE BLOOD MICROCOAGULATION SYSTEM	Class III