HomeUSAEmbecta Medical I, LLC

Embecta Medical I, LLC

USA · Holdrege
✓ Record-verifiedregistrations found in 5 markets

This company has registrations in United States, Brazil, Canada, Taiwan, South Korea — 5 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 0Class II 3Class III 0
plus 21 registration records and 2 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
4registered devices
Class II 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
0active device licences
5 including historic records
TWTaiwanTFDA
3valid device licences
Class II 3
SGSingaporeHSA SMDR
pendingnot queried
KRSouth KoreaMFDS GMP
1GMP quality-system certificates
Import 1
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 States21 registration records, 2 510(k), 0 PMA, 1 excluded
Brazil4 confirmed, 0 excluded
Manufacturer names merged into this page: Embecta Medical II LLC · embecta medical I LLC · embecta Medical Devices (Suzhou) Co., Ltd. · EMBECTA MEDICAL II LLC

Company information

Country
USA
City
Holdrege

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

12024 · K234027
12026 · K260208

FDA listed device types

Syringe, Antistick 1Needle, Hypodermic, Single Lumen 1Syringe, Piston 1

Registration details (sample)

MarketIdentifierNameClass / date
USK260208Ultra-Fine™ SAFETY Insulin Syringe2026-07-13
USK234027embecta Insulin Delivery System2024-08-30
BR82802769005Agulhas para caneta embectaClass II
BR82802769006Seringas Ultra-Fine para insulinaClass II
BR82802769007Agulha de segurança para caneta com proteções automáticas duplasClass II

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