HomeUSABIOFILM, INC.

BIOFILM, INC.

USA · Vista
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, South Korea, Australia — 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
4listed device types
Class I 2Class II 2Class III 0
plus 14 registration records and 17 510(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
0active device licences
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
AUAustraliaTGA ARTG
1active ARTG entries
Class I 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 States14 registration records, 17 510(k), 0 PMA
Manufacturer names merged into this page: BIOFILM, INC.

Company information

Country
USA
City
Vista

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

11994
12001
12003
12004
12008
22014
12015
22017
22020
12021
42022

FDA listed device types

Lubricant, Personal 1Condom 1Lubricant, Vaginal, Patient 1Lubricant, Patient 1

Registration details (sample)

MarketIdentifierNameClass / date
USK221036Astroglide Warming2022-07-01
USK220355Astroglide Ultra Gentle Gel2022-05-26
USK220653Astroglide Glycerin & Paraben Free2022-05-06

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