HomeItalySterylab S.r.l.

Sterylab S.r.l.

Italy · Rho (MI) · www.sterylab.it
✓ Record-verifiedregistrations found in 7 marketsEU SRN IT-MF-000015830

This company has registrations in European Union, United States, United Kingdom, Brazil, Singapore, 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
1UDI-DI device records
Class III 1
USUnited StatesFDA openFDA
2listed device types
Class I 0Class II 2Class III 0
plus 1 registration records and 1 510(k)
UKUnited KingdomMHRA PARD
5registered device records
Class IIa 5
BRBrazilANVISA
28registered devices
Class I 6Class II 22
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
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
2registrations
RURussiaRoszdravnadzor
4active registrations
Class 2a 3Class 2b 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 Union1 raw hits, 0 excluded, 1 confirmed
United States1 registration records, 1 510(k), 0 PMA
United Kingdom5 confirmed, 0 excluded
Brazil28 confirmed, 0 excluded
Manufacturer names merged into this page: STERYLAB S.R.L.

Regulatory identity

EU manufacturer SRN
IT-MF-000015830
UK responsible person
MediLife Ltd

Company information

Country
Italy
City
Rho (MI)
Website
www.sterylab.it
Product categories
Clinical Diagnostics & Therapeutic TechnologiesOncology & Advanced TherapiesMedical oncology devices

Fields marked "pending" have not been obtained yet; that does not mean they do not exist. Risk records (litigation, penalties, operating anomalies) are kept internal and not published.

Business registration

LEI
98450096EI141CC97547
Registration status
Active
Legal form
Società A Responsabilità Limitata (SRL)
Incorporated
1990-07-20
Registered address
VIA MAGENTA 77/6, RHO, 20017
Registration authority
Business Register, no. 10124260158
Registry record updated
2025-12-06

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

12005 · K051506

FDA listed device types

Instrument, Biopsy 1Biopsy Needle 1

Registration details (sample)

MarketIdentifierNameClass / date
EU08058946863984Class III
UK35886COMPLETE CHIBAClass IIa
UK46669SGLClass IIa
UK56709VCSClass IIa
USK051506MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY2005-07-27
BR80686360104Acessórios reutilizáveisClass I
BR80485600002AGULHAS PARA BIÓPSIA DE TECIDO MOLE HISTOLÓGICAS COM CORTE TIPO GUILHOClass II
BR80485600001AGULHAS PARA BIÓPSIAS HEMATOLÓGICAS DE MEDULA ÓSSEAClass II

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