HomeUSACOMBE INCORPORATED

COMBE INCORPORATED

USA · White Plains
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, 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 13 registration records and 9 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class II 1
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
0valid device licences
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
2active ARTG entries
IIb 2
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 States13 registration records, 9 510(k), 0 PMA, 2 excluded
Brazil1 confirmed, 1 excluded
Manufacturer names merged into this page: COMBE INCORPORATED · COMBE INC

Company information

Country
USA
City
White Plains

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

21977
11978
11986
11993
11994
12014
12015
12017

FDA listed device types

Lubricant, Personal 1Condom 1Lubricant, Vaginal, Patient 1Adhesive, Denture, Karaya And Ethylene-Oxide Homopolymer 1

Registration details (sample)

MarketIdentifierNameClass / date
USK171855External Moisturizing Gel2017-07-21
USK150615Vaginal Moisturizing Gel2015-05-01
USK141718INTERNAL HYDRATING GEL2014-11-13
BR10447900001ALGASIVClass II

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