HomeUSABIO MED SCIENCES, INC.

BIO MED SCIENCES, INC.

USA · Allentown
✓ Record-verifiedregistrations found in 6 markets

This company has registrations in United States, Canada, Taiwan, Australia, Israel, Russia — 6 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
3listed device types
Class I 2Class II 0Class III 0unclassified 1
plus 7 registration records and 15 510(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
1active device licences
Class II 1
TWTaiwanTFDA
2valid device licences
Class I 2
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
3active ARTG entries
Class I 3
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
3registrations
RURussiaRoszdravnadzor
1active registrations
Class 1 1
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 States7 registration records, 15 510(k), 0 PMA, 341 excluded
Brazil0 confirmed, 133 excluded
Saudi Arabia0 confirmed, 34 excluded
Canada1 confirmed, 48 excluded
Manufacturer names merged into this page: BIO MED SCIENCES, INC.

Company information

Country
USA
City
Allentown

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

31980
11981
11982
11991
11992
11994
31995
11998
11999
12000
12002

FDA listed device types

Elastomer, Silicone, For Scar Management 1Gauze / Sponge,Nonresorbable For External Use 1Dressing, Wound, Drug 1

Registration details (sample)

MarketIdentifierNameClass / date
USK023136OLEEVA FABRIC2002-10-16
USK002109OLEEVA FOAM2000-08-31
USK990042SILON DUAL-DRESS1999-03-19
CA74650SILON-TSRClass II

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