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Spinreact S.A.U

Spain · Sant Esteve de Bas Girona · www.spinreact.com

✓ Record-verifiedregistrations found in 3 marketsEU SRN ES-MF-000011023

This company has registrations in European Union, Brazil, Russia — 3 overseas markets. EU UDI-DI records ≥300, the first 300 verified individually. 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

≥300UDI-DI device records

IVD general 299ivd-annex-ii-list-a 1

large result set — only the first 300 records were verified, so the real figure is at least this

USUnited StatesFDA openFDA

0listed device types

Class I 0Class II 0Class III 0

plus 0 registration records and 0 510(k)

UKUnited KingdomMHRA PARD

0registered device records

BRBrazilANVISA

49registered devices

Class II 49

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

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

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.

European Union638 raw hits, 0 excluded, 300 confirmed. Large result set — only the first 300 verified

Brazil49 confirmed, 2 excluded

Manufacturer names merged into this page: SPINREACT S.A.U. · SPINREACT SAU · SPINREACT, S. A.

Regulatory identity

EU manufacturer SRN: ES-MF-000011023

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08431673950736	SPINCELL 5 Plus	IVD general
EU	08431673085377	CALPRO-TURBI STOOL COLLECTION TUBE	IVD general
EU	08431673014940	FOB-TURBI STOOL COLLECTION TUBE	IVD general
EU	08431673700065	Anti-A+B Monoclonal	ivd-annex-ii-list-a
BR	80657030004	Cystatin C Calibrator Elitech	Class II
BR	80657030005	Cystatin C Control Elitech	Class II
BR	80657030006	Cystatin C Turbilatex Elitech	Class II

Spinreact S.A.U

Registrations by market

How these numbers were verified

Regulatory identity

Company information

Registration details (sample)

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