Home›Italy›Sentinel CH. SpA

Sentinel CH. SpA

Italy · Milano · www.sentineldiagnostics.com

✓ Record-verifiedregistrations found in 11 marketsEU SRN IT-MF-000012556

This company has registrations in European Union, United States, United Kingdom, Brazil, Canada, Taiwan, Singapore, South Korea, Australia, Israel, Russia — 11 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

6UDI-DI device records

IVD A 3IVD C 2IVD general 1

USUnited StatesFDA openFDA

27listed device types

Class I 9Class II 17Class III 1

plus 37 registration records and 22 510(k)

UKUnited KingdomMHRA PARD

202registered device records

IVD A 41IVD B 9IVD C 16IVD general 135IVD Annex II List B 1

BRBrazilANVISA

65registered devices

Class I 3Class II 62

79 including historic records

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

8active device licences

Class II 8

74 including historic records

TWTaiwanTFDA

59valid device licences

Class I 13Class II 46

SGSingaporeHSA SMDR

27device registrations

CLASS B 22CLASS C 5

KRSouth KoreaMFDS GMP

2GMP quality-system certificates

IVD import 2

AUAustraliaTGA ARTG

27active ARTG entries

IVD Class 1 1IVD Class 2 25IVD Class 3 1

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

4registrations

RURussiaRoszdravnadzor

15active registrations

Class 1 2Class 2a 7Class 2b 6

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 Union6 raw hits, 0 excluded, 6 confirmed

United States37 registration records, 22 510(k), 0 PMA, 1 excluded

United Kingdom202 confirmed, 1 excluded

Brazil65 confirmed, 1 excluded

Canada8 confirmed, 0 excluded

Manufacturer names merged into this page: SENTINEL CH. SPA · SENTINEL CH.SPA · SENTINEL CH SPA

Regulatory identity

EU manufacturer SRN: IT-MF-000012556
UK responsible person: Qarad UK Ltd.

Business registration

Legal name: SENTINEL CH. S.P.A.
LEI: 8156002C62A7192DDF28
Registration status: Active
Legal form: Società Per Azioni (SPA)
Incorporated: 1983-09-30
Registered address: VIA ROBERT KOCH, 2, MILANO, 20152
Registration authority: Business Register, no. 07118040158
Registry record updated: 2026-02-03

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

FDA 510(k) clearances by year

82005

12006

22007

22008

22009

12011

12014

12018

22019

12022

12025

FDA listed device types

showing 8 of 27

Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase 1Alpha-1-Acid-Glycoprotein, Antigen, Antiserum, Control 1Analyzer, Chemistry (Photometric, Discrete), For Clinical Use 1Multi-Analyte Controls, All Kinds (Assayed) 1Lipase-Esterase, Enzymatic, Photometric, Lipase 1Enzymatic Method, Ammonia 1Single (Specified) Analyte Controls (Assayed And Unassayed) 1Photometric Method, Iron (Non-Heme) 1

Registration details (sample)

Market	Identifier	Name	Class / date
EU	08058056685636	SENTiFIT® 300 Analyzer	IVD A
EU	08058056684806	SENTiFIT® 800 Analyzer	IVD A
EU	08058056682888	Ammonia Ultra	IVD C
EU	08058056682895	Ammonia Controls	IVD C
UK	49865	NeuMoDx HAdV Calibrator Kit	IVD general
UK	49864	NeuMoDx HAdV External Control Kit	IVD general
UK	49863	NeuMoDx HAdV Quant Test Strip	IVD general
US	K242585	Cystatin C	2025-05-16
US	K211058	Lp(a) Ultra	2022-12-22
US	K193001	Albumin BCP	2019-12-19
BR	10055310841	Iron/Ferro	Class II
BR	10345162432	Atellica CH Cobre (Cu)	Class II
BR	10345162434	Família Atellica CH Enzima Conversora de Angiotensina (ECA)	Class II
CA	73545	LAMBDA LIGHT CHAINS ASSAY	Class II
CA	73546	KAPPA LIGHT CHAINS ASSAY	Class II
CA	73547	UIBC LIQUID	Class II