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SARSTEDT AG & CO. KG

Germany · Numbrecht

✓ 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

23listed device types

Class I 18Class II 5Class III 0

plus 34 registration records and 7 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

17registered devices

Class I 13Class II 4

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

5 including historic records

TWTaiwanTFDA

8valid device licences

Class I 3Class II 5

SGSingaporeHSA SMDR

5device registrations

CLASS B 5

KRSouth KoreaMFDS GMP

3GMP quality-system certificates

Import 3

AUAustraliaTGA ARTG

9active ARTG entries

Class I 1IVD Class 1 4IIa 3Class Is (sterile) 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

2registrations

RURussiaRoszdravnadzor

19active registrations

Class 1 4Class 2a 15

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 States34 registration records, 7 510(k), 0 PMA, 1 excluded

Brazil17 confirmed, 1 excluded

Manufacturer names merged into this page: SARSTEDT AG & CO. KG · SARSTEDT, INC. · SARSTEDT APS · SARSTEDT AG CO · SARSTEDT AG&CO KG · Sarstedt Ltda

FDA 510(k) clearances by year

11992 · K913622

12001 · K003382

32003 · K032150

12005 · K051019

12023 · K222801

FDA listed device types

showing 8 of 23

Mixer, Blood Tube 1Container, Specimen Mailer And Storage, Sterile 1Tube, Collection, Capillary Blood 1Test, Erythrocyte Sedimentation Rate 1Container, Specimen Mailer And Storage, Temperature Controlled, Non-Sterile 1Micro Pipette 1Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use 1Culture Media, Non-Propagating Transport 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K222801	Safety Lancet	2023-01-25
US	K051019	SAFETY NEEDLE	2005-07-25
US	K032150	SAFETY-MULTIFLY	2003-09-12
BR	80003920014	AGULHA DESCARTAVEL PARA S-MONOVETTE	Class II
BR	80003920042	FAMÍLIA PARA COLETA POC S-MONOVETTE	Class I
BR	80003920032	TUBO DE COLETA MINIVETTE® POCT	Class I

SARSTEDT AG & CO. KG

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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