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R-BIOPHARM AG

Germany · Darmstadt

✓ Record-verifiedregistrations found in 9 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 9 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

4listed device types

Class I 2Class II 2Class III 0

plus 3 registration records and 2 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

63registered devices

Class I 6Class II 57

69 including historic records

SASaudi ArabiaSFDA

0registered imported devices

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

CACanadaMDALL

38active device licences

Class II 35Class III 3

57 including historic records

TWTaiwanTFDA

8valid device licences

Class I 8

SGSingaporeHSA SMDR

5device registrations

CLASS B 5

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

10active ARTG entries

IVD Class 1 2IVD Class 2 7IVD Class 3 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

7active registrations

Class 1 1Class 2a 3Class 2b 3

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 States3 registration records, 2 510(k), 0 PMA, 8 excluded

Brazil63 confirmed, 10 excluded

Canada38 confirmed, 1 excluded

Manufacturer names merged into this page: R-BIOPHARM AG · R-BIOPHARM

FDA 510(k) clearances by year

12011 · DEN110001

12017 · K171511

FDA listed device types

Real Time Nucleic Acid Amplification System 1Reagents For Detection Of Norovirus Nucleic Acid 1P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin 1Protein, Complement, Antigen, Antiserum, Control 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K171511	RIDA GENE Norovirus GI/GII	2017-08-21
US	DEN110001	RIDASCREEN NOROVIRUS 3RD GENERATION EIA	2011-02-23
BR	82890930006	RIDASCREEN® Calprotectin	Class II
BR	82890930007	RIDA® TUBE Calprotectin	Class I
BR	80766140009	RIDASCREEN® Spec. IgG Foodscreen Reagents	Class II
CA	61484	RIDASCREEN CLOSTRIDIUM PERFRINGENS ENTEROTOXIN EIA TEST KIT	Class III
CA	61492	RIDASCREEN VEROTOXIN EIA TEST KIT	Class III
CA	61486	RIDASCREEN CLOSTRIDIUM DIFFICILE TOXIN A/B EIA TEST KIT	Class III

R-BIOPHARM AG

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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