HomeUSABETA BIONICS, INC.

BETA BIONICS, INC.

USA · Irvine
✓ Record-verifiedregistrations found in 1 markets

This company has registrations in United States — 1 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
7listed device types
Class I 0Class II 7Class III 0
plus 8 registration records and 6 510(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
0active device licences
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 States8 registration records, 6 510(k), 0 PMA, 12 excluded
Brazil0 confirmed, 1 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: BETA BIONICS, INC.

Company information

Country
USA
City
Irvine

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

CIK
0001674632
Registration status
Active
Listing status
Listed (BBNX)

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

42023 · K232224
12025 · K252770
12026 · K253976

FDA listed device types

Insulin Pump Secondary Display 1Syringe, Piston 1Alternate Controller Enabled Insulin Infusion Pump 1Set, Administration, Intravascular 1Needle, Hypodermic, Single Lumen 1Interoperable Automated Glycemic Controller 1Tubes, Vials, Systems, Serum Separators, Blood Collection 1

Registration details (sample)

MarketIdentifierNameClass / date
USK253976iLet ACE Pump2026-04-30
USK252770iLet ACE Pump2025-09-29
USK232224iLet® Dosing Decision Software2023-09-22

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