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Centers For Disease Control and Prevention (CDC)

USA · Atlanta

✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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 5Class II 10Class III 0

plus 15 registration records and 37 510(k), 1 PMA

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

0active device licences

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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, 37 510(k), 1 PMA, 2 excluded

Manufacturer names merged into this page: CENTERS FOR DISEASE CONTROL AND PREVENTION

Same-named companies — This database also contains companies with near-identical names: Center For Disease Control and Prevention (Cdc), CENTERS FOR DISEASE CONTROL AND PREVENTION. Company name alone cannot separate their registrations, so the figures below may include either.

FDA 510(k) clearances by year

21981

11982

12000

12006

12008

12010

12011

12012

42013

52014

12015

12016

32017

32018

22019

12020

32022

12024

32025

12026

FDA listed device types

showing 8 of 15

Antisera, All Groups, Salmonella Spp. 1Non-Variola Orthopoxvirus Real-Time Pcr Primer And Probe Set 1Assay, Nucleic Acid Amplification, Bacillus Anthracis 1Antiserum, Vibrio Cholerae, All Varieties 1Bacteriophage And Controls, B. Anthracis Lysis 1Influenza A And Influenza B Multiplex Nucleic Acid Assay 1Variola Virus Nucleic Acid-Based Detection Assay 1Antiserum, Fluorescent, Francisella Tularensis 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K260812	Francisella tularensis Real-time PCR Assay	2026-03-30
US	K252072	Francisella tularensis Real-time PCR assay	2025-09-30
US	K243274	CDC Human Influenza Virus Real-Time RT-PCR Diagnostic Panel: Influenza A/B Typing Kit (VER 2); Influenza A SubTyping Kit (VER 4); Influenza B Genotyping Kit (VER 1.1 and 2); and Influenza A/H5 Subtyping Kit (VER 4)	2025-07-11

Centers For Disease Control and Prevention (CDC)

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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