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IBL INTERNATIONAL GMBH

Germany · Hamburg

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, South Korea, Australia, Israel, Russia — 7 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

12listed device types

Class I 8Class II 3Class III 0unclassified 1

plus 10 registration records and 1 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class II 10

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

41active device licences

Class II 41

73 including historic records

TWTaiwanTFDA

0valid device licences

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

5active ARTG entries

IVD Class 2 5

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

5registrations

RURussiaRoszdravnadzor

3active registrations

Class 1 2Class 2a 1

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 States10 registration records, 1 510(k), 0 PMA, 4 excluded

Brazil10 confirmed, 0 excluded

Canada41 confirmed, 0 excluded

Manufacturer names merged into this page: IBL INTERNATIONAL GMBH

FDA 510(k) clearances by year

12015 · K150528

FDA listed device types

showing 8 of 12

Autoantibodies, Acetylcholine Receptor, Acetylcholine Blocking And Non-Blocking 1Calibrator, Secondary 1Enzyme Immunoassay, Cortisol, Salivary 1Radioimmunoassay, 17-Hydroxyprogesterone 1Radioimmunoassay, Progesterone 1Radioimmunoassay, Estradiol 1Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use 1Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K150528	Cortisol Saliva Luminescence Immunoassay	2015-11-25
BR	80500080010	CORTISOL SALIVA ELISA - Imunoensaio enzimático	Class II
BR	80500080012	TriCat TM ELISA	Class II
BR	80500080006	CORTISOL ELISA - Imunoensaio enzimático	Class II
CA	68645	BORDETELLA PERTUSSIS IGG ELISA	Class II
CA	68646	BORDETELLA PERTUSSIS IGA ELISA	Class II
CA	75656	CORTISOL LUMINESCENCE IMMUNOASSAY	Class II

IBL INTERNATIONAL GMBH

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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