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DRG International, Inc.

USA · Springfield

✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Australia, Israel — 5 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

96listed device types

Class I 54Class II 42Class III 0

plus 137 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

17registered devices

Class II 17

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

23active device licences

Class II 23

53 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

4active ARTG entries

IVD Class 1 1IVD Class 2 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

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 States137 registration records, 0 510(k), 0 PMA, 2 excluded

Brazil17 confirmed, 1 excluded

Canada23 confirmed, 1 excluded

Manufacturer names merged into this page: DRG International, Inc. · DRG INTERNATIONAL, INC.

FDA listed device types

showing 8 of 96

21-Hydroxylase Antibody (21-Ohab) 1Radioimmunoassay, Acth 1Reagent, Borrelia Serological Reagent 1System, Test, Rheumatoid Factor 1Radioimmunoassay, Thyroid-Stimulating Hormone 1Dengue Virus Antigen Assay 1Antigens, All, Leptospira Spp. 1Thyroglobulin, Antigen, Antiserum, Control 1

Registration details (sample)

Market	Identifier	Name	Class / date
BR	80680420109	DRG ESTRONA ELISA	Class II
BR	10230730178	Estriol total ELISA	Class II
BR	10230730196	PLGF ELISA	Class II
CA	78514	DRG LH URINE ELISA	Class II
CA	81913	DRG PROLACTIN ELISA	Class II
CA	81916	17 OH-PROGESTERON(E) ELISA	Class II

DRG International, Inc.

Registrations by market

How these numbers were verified

Company information

FDA listed device types

Registration details (sample)

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