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CENOGENICS CORPORATION

USA · Morganville

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 3 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

15listed device types

Class I 3Class II 12Class III 0

plus 15 registration records and 5 510(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

4active device licences

Class II 3Class III 1

7 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

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 States15 registration records, 5 510(k), 0 PMA

Canada4 confirmed, 0 excluded

Manufacturer names merged into this page: CENOGENICS CORP. · CENOGENICS CORPORATION

FDA 510(k) clearances by year

11985 · K843680

11989 · K894793

11999 · K992397

12003 · K030533

12005 · K042641

FDA listed device types

showing 8 of 15

Antistreptolysin - Titer/Streptolysin O Reagent 1Streptolysin O 1Antigens, Febrile (Weil-Felix), All Groups 1Antiserum, Positive And Negative Febrile Antigen Control Serum 1Antigens (Febrile), Agglutination, Brucella Spp. 1Visual, Pregnancy Hcg, Prescription Use 1Reagent, Occult Blood 1Kit, Test, Pregnancy, Hcg, Over The Counter 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K042641	CHEMVIEW-10	2005-01-07
US	K030533	ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST	2003-04-17
US	K992397	ACCUNATE-ONE STEP, ACCUNATE-ONE STEP CASSETTE	1999-08-26
CA	6660	C.R.P.A. LATEX	Class II
CA	6663	RF LATEX	Class II
CA	6665	ACCUNATE - SENSI	Class II

CENOGENICS CORPORATION

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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