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BUHLMANN LABORATORIES AG

Switzerland · Schonenbuch

✓ Record-verifiedregistrations found in 7 markets

This company has registrations in United States, Brazil, Canada, Taiwan, 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

11listed device types

Class I 8Class II 3Class III 0

plus 14 registration records and 4 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

16registered devices

Class I 2Class II 14

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

9active device licences

Class II 9

30 including historic records

TWTaiwanTFDA

2valid device licences

Class I 1Class II 1

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

12active ARTG entries

IVD Class 1 3IVD Class 2 9

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

1active registrations

Class 1 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 States14 registration records, 4 510(k), 0 PMA

Brazil16 confirmed, 0 excluded

Canada9 confirmed, 0 excluded

Manufacturer names merged into this page: BUHLMANN LABORATORIES AG

FDA 510(k) clearances by year

11995 · K954299

12018 · K181012

22019 · K191718

FDA listed device types

showing 8 of 11

Diluent, Blood Cell 1Colorimeter, Photometer, Spectrophotometer For Clinical Use 1Container, Specimen, Non-Sterile 1Reagents, Specific, Analyte 1Formalin-Saline 1P-Toluenesulphonyl-L-Arginine Methyl Ester (U.V.), Trypsin 1General Purpose Reagent 1Products, Red-Cell Lysing Products 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K191718	Buhlmann fCAL turbo and CALEX Cap	2019-09-24
US	K190784	BUHLMANN fCAL turbo	2019-06-25
US	K181012	BUHLMANN fCAL ELISA	2018-06-04
BR	80102512062	BÜHLMANN Quantum Blue® Adalimumab	Class II
BR	80102512135	BÜHLMANN GanglioCombi MAG ELISA	Class II
BR	80102512136	BÜHLMANN GanglioCombi Light ELISA	Class II
CA	83477	QUANTUM BLUE FCAL	Class II
CA	88997	FLOW CAST HIGHSENS BASOPHIL ACTIVATION TEST (BAT) FLOW CYTOMETRY	Class II
CA	89115	VASOPRESSIN DIRECT RIA	Class II

BUHLMANN LABORATORIES 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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