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Home›USA›OWEN MUMFORD USA, INC.

OWEN MUMFORD USA, INC.

USA · Marietta
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 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
13listed device types
Class I 4Class II 9Class III 0
plus 65 registration records and 23 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class I 4
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
2active device licences
Class II 2
10 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
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 States65 registration records, 23 510(k), 0 PMA
Brazil4 confirmed, 0 excluded
Canada2 confirmed, 0 excluded
Manufacturer names merged into this page: OWEN MUMFORD, LTD. · Owen Mumford Sdn Bhd · OWEN MUMFORD USA, INC. · Owen Mumford Limited · OWEN MUMFORD LTD. · OWEN MUMFORD LIMITED
Same-named companies — This database also contains companies with near-identical names: Owen Mumford Sdn Bhd. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Marietta

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

21995
21997
31998
21999
12000
22001
12012
12016
12018
12021
52022
22023

FDA listed device types

showing 8 of 13
Introducer, Syringe Needle 1Single Use Only Blood Lancet With An Integral Sharps Injury Prevention Feature 1Single Use Only Blood Lancet Without An Integral Sharps Injury Prevention Feature 1Stent, Vaginal 1Syringe, Piston 1Device, External Penile Rigidity 1Multiple Use Blood Lancet For Single Patient Use Only 1Needle, Hypodermic, Single Lumen 1

Registration details (sample)

MarketIdentifierNameClass / date
USK223854Unistik® ShieldLock, Unistik VacuFlip2023-06-30
USK231124Unistik® 3 Single-Use Safety Lancets:- Extra (21G), Normal (23G), Comfort (28G), Gentle (30G)2023-06-27
USK222168Unistik TinyTouch Sterile Single-Use Heel Incision Safety Lancets - Preemie and Full-Term, Unistik Heelstik Sterile Single-Use Heel Incision Safety Lancets - MicroPreemie, Preemie, Full-Term and Toddler2022-11-03
BR80509269003CSYNCClass I
BR80146509044FREESTYLE LANCING DEVICE II\ LANCETADOR FREESTYLE IIClass I
BR80509269002AUTOJECT 2Class I
CA8467NEUROTIPSClass II
CA8577COPAXONE AUTOJECTClass II

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