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Liofilchem, Inc.

USA · Waltham

✓ Record-verifiedregistrations found in 4 markets

This company has registrations in United States, Brazil, South Korea, Australia — 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

pendingnot queried

USUnited StatesFDA openFDA

5listed device types

Class I 2Class II 3Class III 0

plus 40 registration records and 3 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

2registered devices

Class II 2

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

1GMP quality-system certificates

IVD import 1

AUAustraliaTGA ARTG

1active ARTG entries

IVD Class 2 1

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, 3 510(k), 0 PMA, 3 excluded

Brazil2 confirmed, 2 excluded

Canada0 confirmed, 1 excluded

Manufacturer names merged into this page: Liofilchem, Inc. · LIOFILCHEM SRL

FDA 510(k) clearances by year

22025 · K251879

12026 · K261853

FDA listed device types

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

Registration details (sample)

Market	Identifier	Name	Class / date
US	K261853	Gepotidacin GEP 10 µg	2026-07-23
US	K251879	Sulopenem SPM 2 µg	2025-08-12
US	K250885	Ceftobiprole BPR 5 µg Disc	2025-06-23
BR	10097010189	Família Discos e fitas impregnados com agentes antimicrobianos isolado	Class II
BR	80035670028	FAMÍLIA MIC TEST STRIP	Class II

Liofilchem, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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