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Home›USA›Santa Barbara Medco, Inc.

Santa Barbara Medco, Inc.

USA · Santa Barbara
✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Saudi Arabia, 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
12listed device types
Class I 8Class II 4Class III 0
plus 22 registration records and 10 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
0registered devices
this export covers Class I / II only (the cadastro route)
SASaudi ArabiaSFDA
3registered imported devices
low-risk imported devices only; a 2023 snapshot, not updated since
CACanadaMDALL
3active device licences
Class II 3
16 including historic records
TWTaiwanTFDA
0valid device licences
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 States22 registration records, 10 510(k), 0 PMA, 1 excluded
Saudi Arabia3 confirmed, 0 excluded
Canada3 confirmed, 0 excluded
Manufacturer names merged into this page: SANTA BARBARA IMAGING SYSTEMS · Santa Barbara Imaging Systems, Inc.
Same-named companies — This database also contains companies with near-identical names: Santa Barbara Imaging Systems, Inc.. Company name alone cannot separate their registrations, so the figures below may include either.

Company information

Country
USA
City
Santa Barbara

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

11980
31981
11982
11983
11984
11985
12015
12023

FDA listed device types

showing 8 of 12
Light, Surgical, Fiberoptic 1Arthroscope 1Sterilization Wrap Containers, Trays, Cassettes & Other Accessories 1Laparoscope, General & Plastic Surgery 1Accessory Equipment, Cardiopulmonary Bypass 1System, Digital Image Communications, Radiological 1Camera, Television, Surgical, With Audio 1Cart, Emergency, Cardiopulmonary (Excluding Equipment) 1

Registration details (sample)

MarketIdentifierNameClass / date
USK2231168X-10-6XXX Camera Head2023-02-28
USK1525138X-10-XXXX Camera System2015-12-15
USK850492NASAL SEPTAL BUTTON1985-03-07
SAME0000006868SFDAA00001ZEOS 4K UHD Camera Head C-Mount, COMS—
SAME0000006869SFDAA00001ZEOS Zoom Coupler, F=16-34MM—
CA100034TRINITY CAMERA SYSTEMClass II
CA101783PIXA CAMERA SYSTEMClass II
CA101888ZEOS CAMERA SYSTEMClass II

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