HomeUSASTERIPACK USA (LIMITED) LLC

STERIPACK USA (LIMITED) LLC

USA · Lakeland
✓ Record-verifiedregistrations found in 2 markets

This company has registrations in United States, Brazil — 2 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
29listed device types
Class I 9Class II 18Class III 0unclassified 2
plus 37 registration records and 0 510(k)
UKUnited KingdomMHRA PARD
pendingnot queried
BRBrazilANVISA
1registered devices
Class I 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
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 States37 registration records, 0 510(k), 0 PMA, 2 excluded
Brazil1 confirmed, 0 excluded
Canada0 confirmed, 1 excluded
Manufacturer names merged into this page: STERIPACK USA (LIMITED) LLC · STERIPACK USA, LTD

Company information

Country
USA
City
Lakeland

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 listed device types

showing 8 of 29
Coil, Magnetic Resonance, Specialty 1Lamp, Infrared, Therapeutic Heating 1System, Image Processing, Radiological 1Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer 1Transducer, Ultrasonic, Diagnostic 1Tissue Adhesive For The Topical Approximation Of Skin 1Instrument, Biopsy 1Negative Pressure Wound Therapy Powered Suction Pump 1

Registration details (sample)

MarketIdentifierNameClass / date
BR81327670121SWAB NASOFARÍNGEOClass I

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