HomeUSAMILLENNIUM BIOMEDICAL, INC.

MILLENNIUM BIOMEDICAL, INC.

USA · Pomona
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Taiwan, South Korea, Australia — 5 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 0Class III 2
plus 2 registration records and 5 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
5 including historic records
SASaudi ArabiaSFDA
0registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
0active device licences
TWTaiwanTFDA
1valid device licences
Class III 1
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
IIb 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 States2 registration records, 5 510(k), 0 PMA, 20 excluded
Brazil0 confirmed, 3 excluded
Canada0 confirmed, 3 excluded
Manufacturer names merged into this page: MILLENNIUM BIOMEDICAL, INC. · MILLENNIUM BIOMEDICAL INC

Company information

Country
USA
City
Pomona

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 · K003143
22002 · K020122
12004 · K041110

FDA listed device types

Intraocular Lens 1Lens, Intraocular, Toric Optics 1

Registration details (sample)

MarketIdentifierNameClass / date
USK041110MB 105 MILLENNIUM BLADES2004-10-13
USK020122MB 102 MILLENNIUM BLADES2002-02-15
USK011833MB 103 MILLENNIUM BLADES2002-02-15

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