HomeUSACapsoVision, Inc.

CapsoVision, Inc.

USA · Saratoga
✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Brazil, Canada, Taiwan, Singapore, Australia, Israel, Russia — 8 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 1Class III 0
plus 8 registration records and 6 510(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
2 including historic records
TWTaiwanTFDA
1valid device licences
Class II 1
SGSingaporeHSA SMDR
1device registrations
CLASS B 1
KRSouth KoreaMFDS GMP
pendingnot queried
AUAustraliaTGA ARTG
5active ARTG entries
Class I 1IIa 4
HKHong KongMDACS
pendingnot queried
ILIsraelAMAR
1registrations
RURussiaRoszdravnadzor
1active registrations
Class 2a 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 States8 registration records, 6 510(k), 0 PMA
Brazil1 confirmed, 0 excluded
Manufacturer names merged into this page: CapsoVision, Inc. · CAPSO VISION, INC. · CAPSOVISION, INC.

Company information

Country
USA
City
Saratoga

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.

Business registration

Legal name
CapsoVision, Inc
CIK
0001378325
Registration status
Active
Listing status
Listed (CV)

Business registration data from SEC EDGAR, retrieved 2026-09-02. Public registry information only; details of directors and shareholders are not collected.

FDA 510(k) clearances by year

22016 · K161773
12019 · K183192
12020 · K192662
12024 · K242643
12025 · K252480

FDA listed device types

Medical Device Data System 1Bedpan 1System, Imaging, Gastrointestinal, Wireless, Capsule 1

Registration details (sample)

MarketIdentifierNameClass / date
USK252480CE Deliver (DLV)2025-12-19
USK242643CapsoCam Plus (SV-3) Capsule Endoscopy System2024-12-04
USK192662CapsoCam Plus (SV-3) Capsule Endoscopy System2020-02-14
BR10306849029CapsoCam PlusClass II

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