HomeUSAMEDEFIL, INC.

MEDEFIL, INC.

USA · Glendale Height
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 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
2listed device types
Class I 0Class II 2Class III 0
plus 5 registration records and 7 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
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
4active device licences
Class II 4
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States5 registration records, 7 510(k), 0 PMA
Canada4 confirmed, 0 excluded
Manufacturer names merged into this page: MEDEFIL, INC. · MEDEFIL INC.

Company information

Country
USA
City
Glendale Height

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

22000 · K993518
22002 · K020996
22010 · K092491
12012 · K121262

FDA listed device types

Saline, Vascular Access Flush 1Heparin, Vascular Access Flush 1

Registration details (sample)

MarketIdentifierNameClass / date
USK121262MEDEFLUSH NORMAL SALINE I.V. FLUSH SYRINGE-STERILE FIELD READY2012-09-20
USK092491MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES2010-02-03
USK091583MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE2010-01-28
CA76885HEPARIN I.V. FLUSH SYRINGEClass II
CA76886NORMAL SALINE I.V. FLUSH SYRINGEClass II
CA88481NORMAL SALINE I.V. FLUSH SYRINGE - STERILE FIELD READYClass II

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