STRATEC SE

Germany · Birkenfeld · www.stratec.com

✓ Record-verifiedregistrations found in 4 marketsEU SRN DE-MF-000007261

This company has registrations in European Union, United States, United Kingdom, Canada — 4 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

2UDI-DI device records

IVD A 2

USUnited StatesFDA openFDA

9listed device types

Class I 5Class II 4Class III 0

plus 18 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

3registered device records

IVD A 3

BRBrazilANVISA

0registered devices

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

1 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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.

European Union7 raw hits, 5 excluded, 2 confirmed

United States18 registration records, 0 510(k), 0 PMA, 3 excluded

United Kingdom3 confirmed, 2 excluded

Brazil0 confirmed, 2 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: STRATEC SE

Regulatory identity

EU manufacturer SRN: DE-MF-000007261
UK responsible person: Qarad UK Ltd.

Business registration

LEI: 529900ZZJWANAFSPGV30
Registration status: Active
Legal form: Europäische Aktiengesellschaft (SE)
Incorporated: 2018-11-27
Registration authority: Commercial Register, no. HRB 732007
Registry record updated: 2025-09-22

Business registration data from GLEIF, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA listed device types

showing 8 of 9

Clinical Sample Concentrator 1Station, Pipetting And Diluting, For Clinical Use 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1Analyzer, Chemistry, Micro, For Clinical Use 1Automated Pipetting, Diluting And Specimen Processing Workstations For Flow Cytometric Analysis 1Real Time Nucleic Acid Amplification System 1Flow Cytometric Reagents And Accessories. 1System, Test, Automated Blood Grouping And Antibody 1

Market	Identifier	Name	Class / date
EU	04260678680003	KleeYa® Instrument	IVD A
EU	04260678680010	Gemini Compact Microplate Processor	IVD A
UK	56701	KleeYa	IVD A
UK	56718	Gemini	IVD A
UK	56718	Gemini Combo	IVD A

STRATEC SE

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Business registration

FDA listed device types

Registration details (sample)

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