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Home›USA›Bentec Medical OpCo, LLC.

Bentec Medical OpCo, LLC.

USA · Woodland
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Canada, Israel — 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
5listed device types
Class I 3Class II 2Class III 0
plus 5 registration records and 3 510(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
18 including historic records
TWTaiwanTFDA
pendingnot queried
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
pendingnot queried
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
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 States5 registration records, 3 510(k), 0 PMA, 1 excluded
Canada1 confirmed, 0 excluded
Manufacturer names merged into this page: Bentec Medical OpCo, LLC. · BENTEC MEDICAL OPCO, LLC
Same-named companies — This database also contains companies with near-identical names: Bentec Medical, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Woodland

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

21997 · K971411
12001 · K002650

FDA listed device types

Catheter, Irrigation 1Bag, Intestine 1Dressing, Wound, Occlusive 1Biliary Catheter For Irrigation And Contrast Injection, Exempt 1Elastomer, Silicone Block 1

Registration details (sample)

MarketIdentifierNameClass / date
USK002650VAN ANDLE DILATION, EMERALD GUIDEWIRE, MODEL VAD6, 502-7262001-02-16
USK971411DISPOSABLE SILICONE EPISTAXIS CATHETER V-27030/DISPOSABLE SILICONE EPISTAXIS CATHETER KIT V-27030K1997-06-03
USK971517SILICONE PUTTY EAR PLUGS1997-06-02
CA79771ROBERTSON SUPRAPUBIC DRAIN AND TROCAR SYSTEMClass II

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