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Home›Italy›Liofilchem S. R. 1.

Liofilchem S. R. 1.

Italy · Roseto Degli Abruzzi
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 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
5listed device types
Class I 2Class II 3Class III 0
plus 40 registration records and 36 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
5registered devices
Class I 5
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
4 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.

United States40 registration records, 36 510(k), 0 PMA, 3 excluded
Brazil5 confirmed, 1 excluded
Manufacturer names merged into this page: LIOFILCHEM S.R.L. · LIOFILCHEM S.R.L
Same-named companies — This database also contains companies with near-identical names: LIOFILCHEM S.R.L.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
Italy
City
Roseto Degli Abruzzi

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.

FDA 510(k) clearances by year

42016
82017
92018
72019
22020
12021
12023
32025
12026

FDA listed device types

Panels, Test, Susceptibility, Antimicrobial 1Susceptibility Test Discs, Antimicrobial 1Manual Antimicrobial Susceptibility Test Systems 1Transport Medium, Notified Per The Vtm Guidance 1Culture Media, Non-Propagating Transport 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260696MTS Gepotidacin 0.016-256 µg/mL2026-04-17
USK252114MTS Aztreonam-Avibactam 0.016/4 - 256/4 µg/mL2025-10-02
USK251580MTS Sulbactam-Durlobactam 0.004/4 - 64/4 µg/mL (SUD)2025-08-20
BR80002670111URITESTClass I
BR80002670112DERMATESTClass I
BR80002670114Enteropluri-TestClass I

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